|
|
| ||
| Title | ||
| Clinical Evaluation of CS-600 in the Treatment of Pain on Trauma and Postoperative Symptoms: Double-blind Study in Comparison with Mefenamic acid | ||
| Authors | ||
| NAGAYA Ikuro, SAITO Susumu, MIURA Takayuki, KASAI Tsutomu, HARADA Atsushi, YAMAGA Hiroshi, ABEMATSU Norio, OTA Hirotoshi, NIWA Shigeo, SOMIYA Masanori, ONODA Takuo, KASUMI Hideo, KITAO Susumu, TAJIMA Akira, SAKAKIBARA Hiroyoshi, NOTO Kenji, WAKAYAMA Hinao, KINO Yoshitake, | ||
| Institutional affiliation of first author | ||
| Department of Orthopaedic Surgery, Nagoya National Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1985; 1(1): 69-89 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| Double-blind study of CS-600 (CS: 180mg a day) in comparison with mefenamic acid (MF: 1000mg a day) as a control was carried out in several institutes in order to investigate the clinical effectiveness of CS-600 against the pain of trauma and postoperation. The objective cases were 119 for CS group and 110 cases for MF group; 229 cases in total. There was no difference in the background factors of both groups. No statistical significant difference was observed in the final general improvement and usefulness between both groups. However, CS was partly superior to MF in the time required for manifestation of the effect and the improvement according to symptoms. The adverse reaction incidences were as low as 4.2% in CS group and 1.8% in MF group: no serious problem was found in any check point. (author abst.) | ||
| Keywords | ||
| Nonsteroidal Antiinflammatory Agent, CS-600, Loxoprofen Soduim, Mefenamic Acid, Trauma, Postoperative Symptoms, Double-Blind Study | ||
| Serial number | ||
| JRCT85W2227E001 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Comparative Study on Clinical Effects of Timiperone Injection and Sulpiride Injection for Schizophrenia by a Double-blind Test | ||
| Authors | ||
| NAKAZAWA Tsuneyuki, OHARA Kenshiro, NAKASHIMA Mitsuyoshi | ||
| Institutional affiliation of first author | ||
| Department of Neuropsychiatry, Fujita Health University School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1985; 1(2): 235-248 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| In order to examine the effectiveness and the safety of timiperone injection, a new butyrophenone-type psychotropic agent, on schizophrenia, a comparative study was carried out by double-blind method using sulpiride injection as a reference drug. The drugs were studied on 126 patients with schizophernia (timiperone administered to 63 patients and sulpiride administered to 63 patients). The dosage forms containing 4mg of timiperone and 100mg of sulpiride in one ampule (2ml) were used for the study. The drugs were administered by fixed-flexible method (the maximum dose was 6 ampules day) within 14 days. There was a wash out period for the patients who had been treated with antipsychotic agents before the study, and levomepromazine (15-75mg day) was given as a basic therapeutic agent during the period. Final evaluation revealed that there was no significant difference between the results of both drugs in terms of final global improvement rating, overall safety rating and usefulness rating. There was also no significant difference between the drugs in each parameter of psychiatric symptoms (16 parameters). "Talkativeness", "hallucination and disturbance of self-consciousness", "increase of movement" and "delusion" in timiperone-group patients and "increase of movement", "disturbance of other feeling" and "talkativeness" in sulpiride-group patients were improved by 50% or more. As for the accompanied symptoms and adverse reactions, a significant difference was noted in "blood pressure lowering", but there were no differences in the other items. "Blood pressure lowering" was observed in 5 cases of sulpiride-group (63 cases), but none in timiperone-group. Severe adverse reactions were not observed in either groups, which suggests that the safety of timiperone injection was as high as that of sulpiride injection. From these results, it is suggested that timiperone injection is characterized by its improving effect on hallucination and delusion as well as its fast onset of effect when used in schizophrenic patients at acutely aggravated state. (author abst.) | ||
| Keywords | ||
| Timiperone, Sulpiride, Schizophrenia, Double-Blind, Injection | ||
| Serial number | ||
| JRCT85W2227E002 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Evaluation of Tizanidine on Myotonic Painful Diseases of Neck-Shoulder-Arm and Low Back: Investigation of Optimal Dose by Double-blind Method | ||
| Authors | ||
| AOKI Torakichi, MIURA Yukio, SUGAWARA Sachiko | ||
| Institutional affiliation of first author | ||
| Department of Orthopaedic Surgery, Juntendo University School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1985; 1(4): 533-547 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| In order to investigate an optimal dose of tizanidine, a new centrally acting muscle relaxant, for myotonic pains in the neck-shoulder-arm and low back, we compared two doses of tizanidine, 3mg day and 6mg day by an multicentric double-blind method. In statistical analysis, 180 cases (92 of the 3mg group and 88 of the 6mg group) were employed for the final global improvement rating, 212 cases (106 and 106) for the overall safety rating and 188 cases (93 and 95) for the utility rating. In the final global improvement rating, cases rated as "slightly improved" or better were high in both groups: 77.2% in the 3mg group and 80.7% in the 6mg group; there was no significant difference between the two groups. In the overall safety rating, cases rated as "safe" were 88.7% in the 3mg group and 80.2% in the 6mg group. Although there was no significant difference between the two groups, the incidence of side effects from 6mg was slightly higher: drowsiness and dry mouth were observed more frequently. In the utility rating, cases rated as "slightly useful" or better were high in both groups: 72.0% in the 3mg group and 74.4% in the 6mg group, showing no significant difference between the two groups. These results suggest that the optimal dose of tizanidine for myotonic painful diseases of the neck-shoulder-arm and low back was 3mg day. (author abst.) | ||
| Keywords | ||
| Centrally Acting Muscle Relaxant, Tizanidine, Myotonic Painful Diseases, Double-Blind Comparative Study | ||
| Serial number | ||
| JRCT85W2227E003 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Efficacy of FK235, a new Calcium Channel Blocking Agent, in Patients with Angina Pectoris by a Multicenter Cooperation Pilot Trial | ||
| Authors | ||
| NAKAMURA Yoshiro, MIYASHITA Hideo, IIMURA Osamu, UEDA Keiji, TAKAHASHI Nobumitsu | ||
| Institutional affiliation of first author | ||
| Cardiopulmonary Division, Department of Medicine, Keio University School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1985; 1(5): 639-654 | ||
| Research Design | ||
| CCT | ||
| Abstract | ||
| FK235, a newly developed calcium channel blocking agent, was examined for its clinical efficacy and tolerability in 16 in- and 38 out-patients with angina pectoris. An open label fixed and flexible dosage regimen was used in this study. Dosage of FK235 was 2mg orally three times daily (2mg t.i.d.), increasing up to 4mg t.i.d. and maximally 6mg t.i.d. in compliance with patients response. Administration period was 3 to 7 days in in-patients and 2 weeks in out-patients per dose respectively. Overall symptomatic improvement rate more than "improved" were 38.9% in dosage regimen of 2 mg t.i.d., 58.0% of 4mg t.i.d. and 65.0% of 6mg t.i.d. respectively using life table method in those out-patients given 2 weeks' treatment. The figures, excluding those variant and resting forms, were 36.4%, 56.2% and 63.5% respectively. In 10 patients with variant angina pectoris, 8 in- and 2 out-patients, symptomatic improvement more than "improved" was given to 7 by 2mg t.i.d. and to 9 by 4mg t.i.d. Three patients experienced minor side effects of palpitation, facial flush and dizziness considered by hypotention, respectively. Frequency of side effects was totally 5.7%. The results of this study suggest that FK235 is an effective and well tolerated antianginal agent. (author abst.) | ||
| Keywords | ||
| FK235, Calcium Channel Blocking Agent, Angina Pectoris | ||
| Serial number | ||
| JRCT85W2227E004 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Double-blind Controlled Study on Systemic Effects of Topical Difluprednate (DFBA) | ||
| Authors | ||
| TAKEDA Katsuyuki, NAGAI Ryu, ENOMOTO Mitsukuni, NAGAE Hiroaki, NORIMURA Sekishi | ||
| Institutional affiliation of first author | ||
| Department of Dermatology, University of Tokushima School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1985; 1(5): 655-666 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| The three groups each of eight healthy volunteers were treated for three consecutive days with 0.05% difluprednate (DFBA) and 0.12% betamethasone 17-valerate (BV) ointment respectively to study on their systemic effects by means of double-blind controlled study. Daily application of 5g of DFBA, 10g of DFBA and 10g of BV ointment in the respective group was performed under occlusive dressing technique, and the pituitary-adrenocortical functions were daily evaluated during the first three days of treatment and also following four days of observation. Eosinophil counts and blood glucose levels were also measured. Adrenocortical suppression was observed in all three groups from the second day of treatment and the suppression was recovered at the end of study. Level of serum ACTH, cortisol and DHEA-S was lowered apparently and level of blood glucose was elevated. The eosinophile counts, however, was not lowered. The suppression effect of DFBA 5g was lower compared with that of BV 10g, especially in the level of serum DHEA-S. DFBA 10g was slightly lower in its suppression effect than that of BV 10g. (author abst.) | ||
| Keywords | ||
| Difluprednate(DFBA), Systemic Effect, Adrenocortical Suppression, Double-Blind Study | ||
| Serial number | ||
| JRCT85W2227E005 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Evaluation of L-141 Ointment on Arthritis Deformans of Knee | ||
| Authors | ||
| TSUYAMA Naoichi, KUROKAWA Takahide, NAGANO Akira, NIHEI Ryuichi, TACHIBANA Naoya, HANAOKA Kazuo | ||
| Institutional affiliation of first author | ||
| National Rehabilitaion Center for the Disabled Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1985; 1(5): 697-729 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| To evaluate the usefulness of L-141 topicum, a non-steroidal antiinflammatory analgesic, for osteoarthritis of the knee, we performed a multicenter double blind comparative study using FB tablet as a control, which has been widely used in the clinical field, and the following results were obtained. 1) Total cases treated were 275, of which statistically analyzed were 134 cases in L-141 group and 131 cases in FB group, totalling 265 cases. 224 cases (115 in L-141 group and 109 in FB group) were evaluated on final overall improvement, 263 cases (132 in L-141 group and 131 in FB group) on overall safety, 232 cases (117 in L-141 group and 115 in FB group) on usefulness, and all of 265 cases on side effects. 2) There was no significant difference between the two groups in the final overall inprovement rate, although FB group showed slightly higher improvement rate; that is, cases evaluated as "moderate improvement" or better were 49.6% (57 115) for L-141 group and 53.2% (58 109) for FB group. 3) No significant difference in overall improvement was found between the two groups at either first or second week. 4) Incidence rates of side effects were 11.2% (15 134) for L-141 group and 12.2% (16 131) for FB group; however, 2 cases (1.5%) on L-141 topicum and 14 cases (10.7%) on FB tablet were determined to be drug-responsible side effects. Because of the significantly lower incidence of L-141 than that of FB, the safety of L-141 was confirmed. 5) The rates for "useful" or better were 46.2% (54 117) for L-141 group and 50.4% (58 115) for FB group. There was no significant difference between the two groups. Since these results indicated that L-141 topicum had similar clinical efficacy to FB tablet, plus higher degree of safety, L-141 in thought to be a very useful percutaneous drug for the treatment of osteoarthritis of the knee. (author abst.) | ||
| Keywords | ||
| L-141 Topicum, Osteoarthritis of the Knee, Double Blind Clinical Study | ||
| Serial number | ||
| JRCT85W2227E006 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| The Evaluation of Clinical Utility of Afloqualone (HQ-495) on Low back Pain: A Placebo controlled double-blind crossover study in combination with an antiinflamatory agent | ||
| Authors | ||
| MARUO Soji, NAKANO Kengo, TEI Jinshu, YAMAMOTO Katsuhiko, NAKANO Toshihiko, TERAUCHI Masaki, ARISAWA Osamu, MATSUSHITA Isao, YAMASHITA Hitoshi, WADA Gosei, NEGORO Hideaki, YOKOYAMA Masahiro, KITABATAKE Akira | ||
| Institutional affiliation of first author | ||
| Department of Orthopedics, Hyogo College of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1985; 1(6): 843-866 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| The clinical utility of HQ-495 (Afloqualone) in superimposition of the basic therapy with antiinflammatory agent in low back pain was studied in 53 patients by a placebo controlled double-blind crossover design. HQ-495, in a dose of 20 mg and its placebo were given t.i.d. for 1 week, respectively. Ibuprofen, antiinflammatory agent as a basic drug was given in a dose of 200 mg t.i.d. The following results were obtained: 1) Referring to the order effects, no difference was found between the H group (H par P) and the P group (P par H). 2) As regards the period effects, no difference was found between the first week and the second week. 3) Analysis of the drug effect showed in both GIR (Global Improvement Rate) and GUR (Global Utility Rate), HQ-495 was significantly superior to placebo. 4) In each of the following parameters of symptoms and in the corresponding degree of improvement, HQ-495 was also significantly superior to placebo. Subjective symptom: spontaneous pain, Activities of daily living: turning over in bed, standing up, washing, walking, degree of improvement, Objective findings: muscle tension, tenderness, degree of improvement. 5) In stratified analysis of GUR, too, HQ-495 was significantly superior to placebo in each of the strate "Outpatient", "Overall degree of severity: moderate", "Past history: none", "Complication: none", "Patient compliance: just as instructed" and "Concomitant therapy: none". Substantially the same was true with the GIR. 6) Adverse effects were found in 1 case (stomachache) during administration of HQ-495 and in 3 cases (stomach discomfort, anorexia, pain in the left abdomen) during administration of placebo, but these symptoms either disappeared in a short time or were of clinically insignificant severity. In laboratory examination, deviations from physiological ranges were found in 3 cases but they were not as meaningful as suggesting a relation to the drug. 7) The foregoing results clearly indicate the utility of HQ-495 in combination therapy with antiinflammatory agent in various low back pain diseases. (author abst.) | ||
| Keywords | ||
| Muscle Relaxant, Afloqualone, Placebo, Double-Blind Crossover Design, Antiinflammatory Agent, Low Back Pain | ||
| Serial number | ||
| JRCT85W2227E007 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Effect of Buprenorphine 0.3mg i.m. on Post-operative Pain | ||
| Authors | ||
| KAWAMURA Masatoshi, ARAI Kazushige, ISHII Junichi | ||
| Institutional affiliation of first author | ||
| Department of Surgery, Showa University School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1985; 1(6): 887-896 | ||
| Research Design | ||
| CCT | ||
| Abstract | ||
| A group comparison was performed of the effects of buprenorphine and pentazocine in 100 patients who complained of severe pain after surgical operation under GOF anesthesia. In the buprenorphine group 0.3mg of the drug was administered intramuscularly, while in the pentazocine group 30mg of pentazocine and 50mg of hydroxyzine for its potentiation were concomitantly administered intramuscularly. Pain intensity analgesic effect, sedative effect, blood pressure, pulse rate, respiration rate, and adverse effects were observed and determined before dosing and 1, 3 and 5 hours post-dosing. The duration of analgesic effect was also evaluated. The number of patients was 50 in each group and there were no significant differences between the groups in the background factors of patients. Pain intensity was significantly lower in the buprenorphine group than in the pentazocine group at 3 and 5 hours post-dosing, while the analgesic effect was significantly stronger with buprenorphine than with pentazocine at 5 hours post-dosing. The duration of analgesic effect, which was assessed by the time until an additional analgesic was given, was also significantly longer with buprenorphine than with pentazocine. Sedative effect was significantly stronger with pentazocine at 1 hour post-dosing. Both drug was considered to only slightly affect the cardiovascular system. Respiratory depression, which was employed for the evaluation of adverse reaction, occured in two of the buprenorphine group, and one was severe enough to require artificial respiration, but the other was mild and required no treatment. The body weights of these patients were relatively light. As a result, buprenorphine 0.3mg i.m. was proven to manifest a satisfactory analgesic effect and duration. (author abst.) | ||
| Keywords | ||
| Buprenorphine, Pentazocine, Pain after Surgical Operation | ||
| Serial number | ||
| JRCT85W2227E008 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Effects of Midazolam for Pre-medication for Anesthesia: A Double Blind Trial with Hydroxyzine Hydrochloride | ||
| Authors | ||
| MOMOSE Takashi, ITO Kazuto, YAMADA Mitsuru, ENOMOTO Naoyoshi, YAMAZAKI Hiroshi, KUGE Teruyoshi, MIMA Takashi | ||
| Institutional affiliation of first author | ||
| Department of Anesthesiology, Nagoya National Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1985; 1(7): 959-975 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| In order objectively to evaluate the usefulness of midazolam for pre-medication for anesthesia, a double blind trial was conducted with hydroxyzine hydrochloride which is wide in use for pre-medication for anesthesia at the department of anesthesiology of 6 national hospitals. Subjects were the patients who were going to have laparotomy under GOF anesthesia. 0.1mg kg of midazolam was administered i.m. to 60 patients (M group), and 1 mg kg of hydroxyzine hydrochloride to another 60 patients (H group), simultaneously with 0.5mg of atropine sulfate 30 minutes before the anesthesia. 1) Effects for pre-medication in patients on the operation table A) Hypnotic state was significantly better in the H group than in the M group. B) Relief from anxiety was significantly superior in the M group. C) Sedative state was significantly better in the M group. D) Results of overall evaluation of efficacy was significantly better in the M group. 2) Amnestic effects Anterograde amnesia was induced at a significantly higher rate in the M group. 3) Influence on circulation respiration Blood pressure, both systolic and diastolic, was significantly higher in the H group right before the induction of anesthesia. Pulse rate was significantly higher in the M group just before the transfer to the operating room. There was no significant difference in respirtory rate between the H and M groups. 4) Usefulness Midazolam was evaluated by the doctors in charge and according to the standardized evaluation scales to be significantly superior to hydroxyzine hydrochloride in usefulness. (author abst.) | ||
| Keywords | ||
| Pre-Medication, Midazolam, Hydroxydine Hydrochloride, Double Blind Trial | ||
| Serial number | ||
| JRCT85W2227E009 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Influence of Batroxobin (Defibrase) on Clinical Physical Functions and Blood Coagulation Fibrinolysis System of Vibration Syndrome Patients | ||
| Authors | ||
| AGISHI Yuko, IDE Hajime, ASANUMA Yoshihide, FUJIYA Shuichi, UCHIUMI Toshihiko, KONDO Mitsuru | ||
| Institutional affiliation of first author | ||
| Balneotherapeutic Research Institute, Hokkaido University School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1985; 1(8): 1169-1187 | ||
| Research Design | ||
| CCT | ||
| Abstract | ||
| An attempt was made to study by means of an open trial method the usefulness and safety of defibrinogenating therapy with batroxobin (DF-521, Tobishi Pharmaceutical Co., Ltd.) for the treatment of patients with the peripheral disturbance of vibration syndrome in a total of 224 cases in 9 facilities. Batroxobin 10BU was dissolved in 250 or 500ml of normal saline and was intravenously administered every other day once daily for 4 weeks, as a rule. Blood fibrinogen concentrations at the 1st, 2nd, 3rd and 4th weeks following administration were found to be maintained at about 80mg dl, and the relative viscosity of whole blood, measured simultaneously, showed a significant decrease, comparing with the pre-administration level. Comparison of values of the cold loading skin temperature test before and after therapy indicated significant improvements in all items, such as skin temperature at rest, 10-min value during immersion, 5-and 10-min values after immersion, and skin-temperature recovery rates at 5 min. and 10 min. By classifying patients into two groups of disease grades of 1. II and III. IV for analysis, it was found that significant improvements were noted in both groups in all items of the cold loading skin temperature test. With patients classified into groups of recovery rates of <30% and > or = 30% at 5 min. and of <60% and > or = 60% at 10 min, improvement rates were found to be higher in the groups which, prior to administration, had shown lower recovery capacity. Blood flow velocity in digital arteries, which was measured simultaneously with the cold loading skin temperature test before and after therapy, was also found to be significantly higher in the patient group with a skin temperature of less than 30 degrees centigrade at rest before therapy and in the groups with recovery rates of less than 30% at 5 min. and less than 60% at 10 min. before therapy. Evaluation of overall improvement degrees based on functional tests showed cases with "excellent" and "good" comprising 29.2% of the cases, and 62.1% including "fair" cases. By overall improvement degrees of subjective symptoms, cases with "excellent" and "good" were found in 50.3%, and 79.1% including "fair" cases. Evaluation of usefulness showed "very useful" and "useful" is 76.6% of the cases. The rate reached 99.1% when "fairly useful" cases were included. In safty, 92.9% of the cases were rated as having "safety without any problem" and 5.4% "safety with some problem". Side-effects were noted in 17 cases (7.6%). In 10 cases, administration was interrupted either at the judgement of the physician in charge or the desire of patients themselves. The main symptoms comprised uncomfortable sensation, headache and elevations of serum GOP and GPT. It is concluded, therefore, that defibrinogenating therapy with DF-521 is useful and safe for the treatment of the peripheral disturbance of vibration syndrome. (author abst.) | ||
| Keywords | ||
| Defibrinogenation Therapy, Vibration Syndrome, Batroxobin | ||
| Serial number | ||
| JRCT85W2227E010 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| A Comparative Study of Defibrinating Therapy and Convetional Therapy for Sudden Hearing Loss | ||
| Authors | ||
| ASAI Hideyo, KUBO Takeshi, SHIRAISHI Takayuki, MORITA Masahiro, MATSUNAGA Toru, OKUMURA Shinichi, DOI Katsumi, FURUKAWA Yutaka, TAKEMOTO Ichiko, WATANABE Yasuo, HASEGAWA Tetsu, ITO Hiroshi, SUGIMOTO Kazuhiko, SAKAI Kunio, OGAWA Masanori, SAIKA Hiroshi, ISHIDA Minoru, OZAK | ||
| Institutional affiliation of first author | ||
| Department of Otolaryngology, Osaka University Medical School | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1985; 1(8): 1189-1199 | ||
| Research Design | ||
| CCT | ||
| Abstract | ||
| The results obtained by conventional therapeutics mainly using steroids were compared with those of defibrinating therapy (DF) for patients having sudden hearing loss. 1) Although more patients received treatment within the 14-day period from the onset of their symptons, no difference was noted in the other backgrond factors. 2) Further improvement of hearing ability above the markedly improved level was observed in 13 (39.4%) of 33 patients of the DF group with no significant difference observed in 16 (40.0%) of the 40 patients who received the conventional therapy. On the other hand, the symptoms remained unchanged in 32.5% of the conventional group as opposed to 18.2% of the DF group. 3) Although no difference was noted between the two groups in terms of the improvement of subjective symptoms such as dizziness and obstructive feeling of ear, tinnitis was more favorably improved in the conventional group. 4) No appreciable difference was recognized between the two groups with respect to developing a negative reaction. However, there were such problems in 3 patients of the DF group and in 4 patients of the conventional group. 5) No difference was noted between the two groups in terms of the usefulness of this therapy. From the above results, DF therapy is considered to be one of the therapeutic methods worth adopting to patients experiencing sudden hearing loss. (author abst.) | ||
| Keywords | ||
| Sudden Hearing Loss, Defibrinating Therapy, Batroxobin | ||
| Serial number | ||
| JRCT85W2227E011 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Phase I Study of SC-29333 (Synthetic Prostaglandin E1 Analog): No.1 Single Dose Study | ||
| Authors | ||
| NAKAMURA Takashi, KINOUCHI Takashi, YOSHIDA Hisayoshi, OKUNI Atsushi, NAKAMURA Kosei, NEMOTO Yoko, SHIMIZU Naokata | ||
| Institutional affiliation of first author | ||
| First Department of Medicine, Teikyo University School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1985; 1(9): 1233-1247 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| In order to investigate the safety of single doses of SC-29333, a synthetic prostaglandin E1 analog, we administered single oral doses of 50mcg or 200mcg in a cross-over, single-blind trial in six healthy volunteers. Each group of three subjects received either 50mcg or 200mcg. After one week, the doses were crossed over. Neither dose produced any abnormal clinical symptoms. Moreover, although diarrhea has been associated with prostaglandins, neither dose of SC-29333 produced diarrhea. No significant effects were seen in blood pressure, pulse rate, ECG, body temperature, or bleeding time. Moreover, there were no abnormalities in urinalysis, biochemistry or hematology values. However, a mild increase in eosinophils was seen in a few subjects and should be studied further. We conclude that single doses of SC-29333 were safe and well-tolerated and that multiple doses of SC-29333 should be evaluated. (author abst.) | ||
| Keywords | ||
| SC-2933, Misoprostol, Synthetic Prostaglandin E1, Tolerance Study, Single Dose, Volunteers | ||
| Serial number | ||
| JRCT85W2227E012 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Investigation on the Optimal Dose of Terfenadine: Result by Double Blind Study, Double Dummy Method, for Chronic Urticaria | ||
| Authors | ||
| KUKITA Atsushi, HARADA Shotaro, MIURA Yusho, ISHIHARA Masaru, TAKAHASHI Hisashi, NONAMI Eiichiro, NAGASHIMA Masaji, TOMIZAWA Takayoshi, MORI Shunji, ASADA Yasuo, YAMAMOTO Shoso, SHIMAO Shuhei, TAKEDA Katsuyuki, URABE Harukuni, YOSHIDA Hikotaro, TASHIRO Masaaki, OGAWA Nob | ||
| Institutional affiliation of first author | ||
| Department of Dermatology, National Defense Medical College | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1985; 1(9): 1283-1295 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| In order to determine the optimal dose of terfenadine, a new antihistamine, in Japan, a double blind comparison of terfenadine 40mg b.i.d. (80mg day, 40mg group) with terfenadine 60mg b.i.d. (120mg day, 60mg group) was carried out in patients with chronic urticaria. As for the therapeutic effects, 60mg group was observed to have a significantly higher incidence of "remarkably improved" cases. The overall incidence of adverse reactions in both groups was identical, however, the incidence and the severity rating of drowsiness and fatigue were significantly lower in 40mg group. As for the usefulness, 60mg group was found to have a tendency of significant superiority to 40mg group. From these results it was concluded that 60mg b.i.d. (120mg day) should be the optimal dose of terfenadine in Japan. (author abst.) | ||
| Keywords | ||
| Terfenadine, Optimal Dose, Chronic Urticaria, Double Blind Study | ||
| Serial number | ||
| JRCT85W2227E015 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Evaluation of Therapeutic Effects of Terfenadine on Chronic Urticaria: Double Blind Comparative Study with Clemastine | ||
| Authors | ||
| KUKITA Atsushi, HARADA Shotaro, MIURA Yusho, SHIRATO Akira, TAGAMI Hachiro, OKAMOTO Shoji, KAGAWA Saburo, NISHIKAWA Takeji, ISHIHARA Masaru, NAGASHIMA Masaji, NIIMURA Michito, TAKAHASHI Hisashi, SHISHIBA Keiko, TOMIZAWA Takayoshi, MORI Shunji, HIRONE Takae, YAMADA Mizuho | ||
| Institutional affiliation of first author | ||
| Department of Dermatology, National Defense Medical College | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1985; 1(9): 1297-1310 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| The therapeutic effects and clinical usefulness of terfenadine were evaluated on patients with chronic urticaria in a double blind comparative study using clemastine as a control drug with following results. 1) As for the therapeutic effects, remarkable and moderate improvements of symptoms were observed on 76.6% of patients treated with terfenadine and on 71.4% of patients treated with clemastine. There was no significant difference between the therapeutic effects of terfenadine and clemastine. 2) The incidence of adverse reactions was significantly lower (p<0.05) for the terfenadine treatment (17.6%) than for the clemastine treatment (29.7%). 3) The incidence of drowsiness and fatigue was significantly lower (p<0.05) for the terfenadine treatment. No significant difference was observed in the incidence of other side effects. 4) There was no significant difference between the evaluation rate of therapeutic usefulness (extremely useful and useful) of the terfenadine (72.9%) and clemastine (65.8%). 5) It may be concluded that terfenadine is a drug of choice because of its low sedation level for the treatment of patients with chronic urticaria many of whom are out-patients performing work and daily practice. (author abst.) | ||
| Keywords | ||
| Terfenadine, Therapeutic Effects, Chronic Urticaria, Double Blind Comparative Study | ||
| Serial number | ||
| JRCT85W2227E016 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Usefulness of Timiperon Injection (DD-3480) for Schizophrenia: Double-blind Multi-center Comparative study with Haloperidol Injection | ||
| Authors | ||
| SUGANO Keiju, SHIMAZONO Yasuo, TORU Michio, MORI Atsuyoshi, KARIYA Tetsuhiko, MURASAKI Mitsukuni, ETO Toshikuni, MIYAMOTO Tadao, KOMAHASHI Kenji, MIYASAKA Matsue, MORI Harunobu, OKUMA Fumio, NAGASE Teruyoshi, NAGATA Toshihiko, TAKAHASHI Yoshindo, HASEGAWA Kazuo, YAMAZUMI | ||
| Institutional affiliation of first author | ||
| Haryugaoka Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1985; 1(9): 1311-1328 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| The clinical efficacy and safety of timiperone injection (TP), a new butyrophenone derivative, in schizophrenia were studied in comparison with haloperidol injection (HPD) by double-blind method. The total 106 patients were subjected to analysis (52 of TP and 54 of HPD). 4 mg of TP was considered equipotent to 5 mg of HPD. The treatment continued not more than 7 days. In final global improvement rating, TP was comparable to HPD. Improvement rate (slight to marked improvement) was 81% and 80% in TP and HPD, respectively. Stratified analysis revealed that TP was significantly superior to HPD in the patients of "markedly severe" of global severity and in "not more than 1 year" of illness period. On the other hand, HPD was significantly superior to TP in "without anti-parkinsonian drugs". Among 16 psychiatric symptoms, HPD was significantly superior to TP in "motor retardation" and "rapport". Side effects were observed in 35 patients of TP and 26 patients of HPD. HPD was superior in overall safety rating, but there was no difference in incidence of each side effect. In general usefulness rating, TP was comparable to HPD. Usefulness rates of TP and HPD were 81% and 76% (slight to marked usefulness), respectively. In conclusion, it is suggested that timiperone injection is an excellent anti-psychotic agent that exhibits high improvement rate for a short period, and is comparable to haloperidol injection. (author abst.) | ||
| Keywords | ||
| Timiperone, Haloperidol, Butyrophenone Derivative, Schizophrenia, Injection, Double-Blind Study | ||
| Serial number | ||
| JRCT85W2227E017 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Comparison of Anti-manic Efficacy of Timiperone Injection and Haloperidol Injection by Double-blind Controlled Study | ||
| Authors | ||
| INANAGA Kazutoyo, NAKAMURA Jun, TAKAHASHI Ryo, OTSUKI Saburo, SAMEJIMA Takeshi, SARAI Keisuke, NAKANE Yoshibumi, NAKAZAWA Tsuneyuki, OHARA Kenshiro, ASADA Shigeya, OGAWA Nobuya | ||
| Institutional affiliation of first author | ||
| Department of Neuropsychiatry, Kurume University School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1985; 1(9): 1329-1344 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| Effectiveness and safety of timiperone injection (TP) were studied on manic patients using haloperidol injection (HPD) as a reference drug by double-blind method TP or HPD was administered within a week. 4 mg of timiperone was considered equipotent to 5 mg of haloperidol. Total 53 patients (23 in TP and 30 in HPD) were subject to analysis. In final global improvement and general usefulness ratings, there was a tendency that TP was superior to HPD in slight to marked improvement, and moderate to marked usefulness, respectively. But, there was no significant difference between two drugs. Global improvement rating revealed that TP showed faster onset of therapeutic effect than HPD. TP was significantly superior to HPD in moderate to marked improvement in terms of global improvement rate of the following symptoms: emotional stability (irritability, emotional movability), psychomotor activity, self-controllability, scope of activity, thought process, thought (grandeur), expression, attitude, speech and voice, interference, insight into disease, disturbance in falling asleep, and disturbance in sleeping sound. With regard to overall safety rating and abnormal laboratory findings, there was no significant difference between two drugs. These results suggest that timiperone injection is as excellent as haloperidol injection for the treatment of mania. (author abst.) | ||
| Keywords | ||
| Timiperone, Haloperidol, Injection, Anti-Manic Efficacy, Butyrophenone Derivative, Double-blind study | ||
| Serial number | ||
| JRCT85W2227E018 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Evaluation of Defibrinogenation Therapy(Batroxobin) on Chronic Arterial Occlusive Disease: Double-blind Study in Comparison with Niceritol | ||
| Authors | ||
| FURUKAWA Kinichi, MISHIMA Yoshio, SAKAGUCHI Shukichi, TANABE Tatsuzo, KATSUMURA Tatsuki, SAKUMA Akira | ||
| Institutional affiliation of first author | ||
| Department of Surgery, Tokyo Medical University | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1985; 1(10): 1413-1427 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| We performed a double blind experiment of batroxobin, a defibrinogenation agent, to compare its clinical efficiency with a control of niceritrol in 120 cases of chronic arterial obstruction of the extremities with ischemic ulcer. The result was as follows: 1) No significant difference in efficiency was observed by the attending doctors between the groups of batroxobin and niceritrol. The result was also the same when judged with the standards of improvement advocated by the subcommittee. 2) The ulcer and granulation improved better in both treatment groups in terms of the ulcer regression and granulation improvement. A significant ulcer regression occurred in 2-4 weeks in batroxobin group and in 4 weeks in niceritrol group. 3) No significant difference was present in the general improvement including subjective symptoms. They both are assumed to have worked well curing the ulcer. 4) Although some symptoms appeared in 2 cases of batroxobin group, they were not clearly related to its administration. Laboratory examination revealed no side effects during and after the treatment. So we considered it to be a safe drug. In view of the above, we concluded that batroxobin was a useful drug to treat chronic obstructive disorders of the artery with ulcers. (author abst.) | ||
| Keywords | ||
| Defibrinogenation, Batroxobin, Uler, Chronic Arterial obstruction | ||
| Serial number | ||
| JRCT85W2227E020 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Efficacy of Defibrinogenation Therapy on Perpherial Circulatory Disturbance of Patients with Vibration Syndrome: Comparative Study with Prostaglandin E1 | ||
| Authors | ||
| NASU Yoshiro, HABU Kyusaku | ||
| Institutional affiliation of first author | ||
| Department of Orthopedic Surgery, San-in Rosai Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(1): 81-96 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| Batroxobin was compared with prostaglandin E1 to evaluate on clinical efficacy on perpherial circulatory disturbance of patients with vibration syndrome. Prostaglandin E1 was given 60microg day every day and batroxobin was given 10BU every other day, and the both preparations were administered for 4 weeks. As to the usefulness rating, batroxbin was superior to prostaglandin E1 by the statistical analysis on the figures protted on visual analog scale, but there were no significant difference between the two groups in four classfied rating scale method. As for subjective global improvement rating, there were no significant difference between the two groups but batroxobin was superior to prostaglandin E1 in subtype of symptoms. The results of objective improvement rating were almost same with the subject one. (author abst.) | ||
| Keywords | ||
| Batroxobin, Prostaglandin E1, Perpherial Circulation Disturbance, Vibration Syndrome | ||
| Serial number | ||
| JRCT86W2227E001 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Dose finding Study of OU-1308 for Gastric Ulcer | ||
| Authors | ||
| MIYOSHI Akima, TSUNEOKA Kenji, TAKEUCHI Tadashi, OKABE Haruya, TAKEUCHI Toshihiko, NAKAZAWA Saburo, KOBAYASHI Kenzo, NAKAJIMA Toshio | ||
| Institutional affiliation of first author | ||
| Shizuoka General Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(2): 163-184 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| A dose-finding clinical study of OU-1308 was conducted in patients with gastric ulcer at dose levels of 10microg day (L group), 20microg day (M group) and 30microg day (H group). Allotment of dose to each patient was made according to a table of random numbers. The patients analyzed comprised 73 cases for L group, 62 for M group and 66 for H group, totalling 201 cases. The results were as follows: 1) Improvement rates of subjective objective symptoms were 75%, 92% and 81% in L, M and H groups, respectively, after 4 weeks of treatment, and 82%, 98% and 88%, respectively, after 8 weeks of treatment, demonstrating a significant difference between L and M groups. 2) Accumulated healing rates assessed by endoscopy were 12.5%, 29.6% and 11.3% in L. M and H groups, respectively, after 4 weeks of treatment, and 40.4%, 74.1% and 58.1%, respectively, after 8 weeks of treatment, revealing a significant difference between L and M groups. 3) Efficacy rates assessed by overall improvement rating were 66.1%, 80.0% and 69.0% in L, M and H groups, respectively. 4) Incidences of side effects assessed by overall safety rating were 10.5%, 4.8% and 10.6% in L, M and H groups, respectively, resulting in the lowest incidence in M group. 5) Usefulness rates assessed by usefulness rating were 64.1%, 80.0% and 56.7% in L, M and H groups, respectively, demonstrating a significant difference between M and H groups. The above results suggest that OU-1308 is a very useful drug for the treatment of patients with gastric ulcer. The optimal dose was considered to be 5microg q.i.d.. (author abst.) | ||
| Keywords | ||
| Prostaglandin, OU-1308, Gastric Ulcer, Dose Finding Study | ||
| Serial number | ||
| JRCT86W2227E002 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Evaluation of OU-1308 in the Treatment of Gastric Ulcer: Multicenter Double-blind Comparison with Cetraxate Hydrochloride as the Control | ||
| Authors | ||
| MIYOSHI Akima, TSUNEOKA Kenji, TAKEUCHI Tadashi, OKABE Haruya, TAKEUCHI Toshihiko, NAKAZAWA Saburo, KOBAYASHI Kenzo, NAKAJIMA Toshio | ||
| Institutional affiliation of first author | ||
| Shizuoka General Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(2): 185-210 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| OU-1308, a prostaglandin E1 derivative, was examined in 67 institutions in double-blind comparison using cetraxate hydrochloride as the control for objective evaluation of its clinical efficacy, safety, and usefulness in the treatment of gastric ulcer. Enrolled were those patients whose ulcer was in active stage (A1 or A2): as a rule, they were outpatients. As to drug administration, a 5microg dose of OU-1308 and a 200 mg dose of cetraxate hydrochloride were given 4 times a day for 8 weeks. A total of 221 patients (113 patients given OU-1308; 108 patients given cetraxate hydrochloride) were statistically analized. According to endoscopic examination, the healing rate at week 8 was 53.3% with OU-1308 and 54.2% with cetraxate hydrochloride: the ulcer improvement rate was 71.4% with OU-1308 and 73.7% with cetraxate hydrochloride. There was no significant difference between these drug groups. As to the drug effect on subjective objective symptoms, however, the improvement rate was 79.0% with OU-1308 and 66.7% with cetraxate hydrochloride; OU-1308 tended to be superior. In terms of overall drug efficacy, the efficacy rate was 72.4% for OU-1308 while it was 68.4% for cetraxate hydrochloride. There was no significant difference between the groups. Incidence of adverse effects was 6.2% with OU-1308 and 3.7% with cetraxate hydrochloride; no significant difference was seen between the groups and neither group showed severe adverse effects. The usefulness rate calculated on the basis of the efficacy and safety described above was 67.3% for OU-1308 and 62.4% for cetraxate hydrochloride. Thus, it has been concluded that like cetraxate hydrochloride, OU-1308 is a clinically useful drug as antiulcer agent which potentiates defensive factors. (author abst.) | ||
| Keywords | ||
| Prostaglandin, OU-1308, Cetraxate Hydrochloride, Gastric Ulcer, Double-Blind | ||
| Serial number | ||
| JRCT86W2227E003 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Evaluation of Tolfenamic Acid on Acute Upper Respiratory Tract Inflammation: Multi-center Double-blind Study with Ibuprofen | ||
| Authors | ||
| NAGAOKA Shigeru, NAKAMURA Seiichi, UMEHARA Yumiko, NAGAHAMA Fumio, OKAYASU Masahito, NOGUCHI Eisei, TANAKA Kazumasa, MORISE Masanori, KAWAI Mitsuru, OKOCHI Toshikazu, SUMIKAWA Kazuhide, YAMAKIDO Michio, NAGANO Hitoshi, HIROSE Takashi, KURODA Rensuke, KOJIMA Yoshitomo, HI | ||
| Institutional affiliation of first author | ||
| Department of Pneumology, Tokyo Metropolitan Hiroo General Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(2): 221-250 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| The effect of tolfenamic acid (100mg, 3 times a day) on acute inflammation was evaluated clinically on 236 patients (15 years old or more) with the acute upper respiratory tract infection (or common cold syndrome), who were within 2 days of the onset. A double blind test was employed using ibuprofen (200mg, 3 times a day) as control. The examination was carried out in association with many hospitals in the whole country. The drug was administered for 3 day. Its results showed that tolfenamic acid is as effective as ibuprofen in relieving general symptoms, such as fever, pain, acute inflammatory symptoms of the upper respiratory tract, and langour. Symptoms which appeared to be side effects of administration of the drug were noted in 8 of 113 cases analysed (7.1%); however, those, mostly gastrointestinal symptoms of mild degrees, disappeared rapidly during the course of administration or after administration was discontinued. Tolfenamic acid is, therefore, considered to be a useful anti-inflammatory agent. (author abst.) | ||
| Keywords | ||
| Tolfenamic Acid, Upper Respiratory Tract Inflammation, Double-Blind Study | ||
| Serial number | ||
| JRCT86W2227E004 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Dose Finding Study of an Antiallergic Drug Amoxanox (AA-673) for Bronchial Asthma | ||
| Authors | ||
| SHIDA Takao, YUI Yasuo, SATO Hiroshi, KISHIMOTO Susumu, TAMURA Masashi, MICHIMATA Mamoru, SUDO Morio, MORI Hidemitsu, KITAZAWA Shunichi, TAKISHIMA Tamotsu, MUE Suetsugu, TAMURA Gen, KOBAYASHI Setsuo, FUEKI Ryuzo, SUNAGA Yoshinobu, KUWABARA Hidemasa, TANAKA Tetsuji, ARAI M | ||
| Institutional affiliation of first author | ||
| Clinical Research Center for Allergy and Rheumatology, National Sagamihara Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(3): 399-415 | ||
| Research Design | ||
| CCT | ||
| Abstract | ||
| AA-673 was studied for its optimal dose in adult patients with bronchial asthma consisting of two groups: a low dose group (Group L) given 37.5mg daily, divided into 3 equal parts, and a high dose group (Group H) given 150mg daily, divided into 3 equal parts, every day, for 4 weeks, respectively. 1) A total of 88 patients were enrolled in the study: 42 assigned to Group L and 46 to Group H (including 6 who received an increased daily dose of 300mg from 3 weeks). Analysis of the background characteristics of the patients revealed that there was a bias in the background factors between the 2 groups: more patients with "atopic" and more with "mild" bronchial asthma in Group L, and more patients with "infectious" and more with "moderate to severe" bronchial asthma in Group H. 2) The final global improvement ratings for the 2 groups were stratified by the disease type, "atopic", "mixed", and "infectious" and also by the disease severity rating, "mild" and "moderate to severe". The improvement rate by "moderate" or better improvement was higher for Group H than for Group L in either stratum of the disease type or disease severity rating. The improvement rate was higher in decreasing sequence of "atopic", "mixed", and "infectious" in both Groups L and H. Especially, no "moderate" or better improvement was achieved for the "infectious" stratum in Group L, while a higher improvement rate was achieved for all disease strata in Group H than in Group L.. 3) Changes in the asthma rating score in the 2 groups were stratified by the initial score (in the control observation period) : a greater decrease in the score was attained for the stratum of "the initial score of > or = 100 to <200" in Group H than in Group L.. 4) The global improvement rating indicated a higher improvement rate at 4 weeks of AA-673 medication than at 2 weeks. 5) Side effects of the medication were observed in 3 of the 42 patients (7.1%) of Group L and 7 of the 46 patients (15.2%) of Group H, but none of them were severe. From the results, it may be anticipated that AA-673 on a dosage regimen of 50mg 3 times daily will be useful in treating bronchial asthma. (author abst.) | ||
| Keywords | ||
| Amoxanox (AA-673), Bronchial Asthma, Dose Finding Study | ||
| Serial number | ||
| JRCT86W2227E005 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Evaluation of TA-079 (Nicergoline) in the Treatment of Cerebrovascular Disorders: Dose Finding Study in Well Controlled Trial | ||
| Authors | ||
| OTOMO Eiichi, HIRAI Shunsaku, HASEGAWA Kazuo, KATO Nobukatsu, ARAKI Goro, KUZUYA Fumio, UTSUMI Shozaburo, HANDA Hajime, SARAI Keisuke, FUJISHIMA Masatoshi | ||
| Institutional affiliation of first author | ||
| Department of Internal Medicine, Yokufukai Geriatric Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(3): 417-466 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| In order to investigate an optimal dose of TA-079 (nicergoline) for cerebrovascular disorders and compare the utility with Hydergine, we carried out the trial at two doses of TA-079, 15mg day (T-15 group) and 30mg day (T-30 group) and 6mg day of Hydergine (HYD group) for 8 weeks or more by a multicentric well controlled method. Results obtained are as follows; 1) Total of 282 cases were evaluated; T-15 group was 96 cases, T-30 group 94 cases and HYD group 92 cases. 2) In the final global improvement rating, number of cases rated as "Moderately improved" or better were 29.2% in the T-15 group, 33.0% in the T-30 group and 16.3% in the HYD group, "Slightly improved" or better were 72.9%, 75.5% and 63.0%, respectively. 3) In the final global safety rating, number of cases rated as "Completely safe" were 96.9% in the T-15 group, 93.6% in the T-30 group and 95.7% in the HYD group. 4) In the final utility rating, number of cases rated as "Moderately useful" or better were 33.3% in the T-15 group, 39.4% in the T-30 group and 19.6% in the HYD group, "Slightly useful" or better were 72.9%, 73.4% and 58.7%, respectively. 5) As for indivisual symptoms, TA-079 group showed high improvement rating in such symptoms as heavy feeling of head, headache, dizziness, reduced spontaniety, anxiety and irritability, depressive mood and disorientation. 6) No significant differences were observed between the three groups in the frequency of adverse reactions and laboratory findings. Finally, it was concluded that the optimal dose of TA-079 was considered as 15mg day, and TA-079 was found more useful than Hydergine in the treatment of cerebrovascular disorders. (author abst.) | ||
| Keywords | ||
| TA-079, Nicergoline, Dose Finding Study, Cerebrovascular Disorders, Hydergine | ||
| Serial number | ||
| JRCT86W2227E006 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Evaluation of Alacepril (DU-1219) in Monotherapy in Essential Hypertension: Double-blind Comparative Study with Captopril | ||
| Authors | ||
| IKEDA Masao, ITO Keiichi, IIMURA Osamu, YOSHINAGA Kaoru, KAJIWARA Nagao, KANEKO Yoshihiro, MURAKAMI Eiji, MIZUNO Yasushi, KUMAHARA Yuichi, OGIHARA Toshio, KOKUBU Tatsuo, OMAE Teruo, ARAKAWA Kikuo, TANAKA Tsuneo | ||
| Institutional affiliation of first author | ||
| Department of Internal Medicine, National Cardiovascular Center | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(4): 527-565 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| Multi-centered, double-blind studies were performed to investigate the clinical utility of alacepril (25-50 mg in 2 divided doses a day) versus captopril (37.5-75mg in 3 divided doses a day) as a reference drug, in mild to moderate essential hypertensive patients, adopting nationwide 133 facilities. One hundred and 4 cases administered alacepril and 100 cases adiminstered captopril were analyzed and the following results were obtained. 1) In background characteristics, some imbalance was found concerning three factors, SBP, DBP and MBP in observation term (intial placebo period), between the two groups, but no significant difference was noted in the other characteristics. 2) Antihypertensive efficacy rates as assessed marked fall plus fall in alacepril and captopril groups were 51.0% and 61.0% by the attending physicians. These rates showed no statistically significant difference between the two groups, whereas significant one was found in the U test when the number of cases in distribution of blood pressure falls was analyzed. The efficacy rates of alacepril and captopril by the protocol comittee were 53.8% and 58.0%, respectively, and no significant difference was noted between the two groups. 3) Both in alacepril and captopril groups, significant falls in systolic, diastolic and mean blood pressure from base line (initial placebo period) were observed two weeks after treatment, and there was no significant difference between the two groups in ten weeks. However, in analysis on the fall rates at the twelfth week, captopril group was superior to alacepril group in systolic pressure, whereas no significant difference between the two groups was noted in diastolic one. 4) The subjective-symptoms-improvement rating judged by the attending phycicians were 51.2% in alacepril group and 46.2% in captopril group. There was no significant difference between the two groups. 5) The adverse reactions reported by the attending physicians were 11 cases (10.6%) in alacepril group and 11 cases (11.0%) in captopril group with no difference in the two groups. The number of cases in whom the study was discontinued or in whom the dose of drugs was reduced were 2 cases (1.9%) in alacepril and 6 cases (6%) in captopril, but all were not serious and disappered after discontinuance of the drugs or during the treatment. 6) In the protocol comittee's evaluation of the results of the laboratory tests and the adverse reactions, 15 patients (14.4%) in alacepril group and 13 patiants (13.0%) in captopril group were assigned a score indicative of a clinical problem. There was no significant difference between the two groups. 7) Utility rates as assessed very useful plus useful by the attending plysicians were 53.8% in alacepril group and 62.0% in captopril group, while these by the protocol comittee were 50.0% in alacepril group and 55.0% in captopril group, respectively. For these utility rates, no statistical significant difference was found between the two groups. From the above results, it can be concluded that alacepril, when administered alone 12.5-25mg twice-a-day to mild to moderate essential hypertension, indicates utility fully comparable to that of captopril administered 12.5-25mg three times a day. (author abst.) | ||
| Keywords | ||
| Alacepril, DU-1219, Double-Blind study, Monotherapy, Essential Hypertension | ||
| Serial number | ||
| JRCT86W2227E007 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Evaluation of Alacepril (DU-1219) in Combination Therapy on Essential Hypertension: Double blind Comparison study with Captopril in Combination Therapy with Antihypertensive Diuretics | ||
| Authors | ||
| IKEDA Masao, OGIHARA Toshio, KUMAHARA Yuichi, IIMURA Osamu, YOSHINAGA Kaoru, KAJIWARA Nagao, KANEKO Yoshihiro, MURAKAMI Eiji, MIZUNO Yasushi, ITO Keiichi, KOKUBU Tatsuo, OMAE Teruo, ARAKAWA Kikuo, TANAKA Tsuneo | ||
| Institutional affiliation of first author | ||
| Department of Internal Medicine, National Cardiovascular Center | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(4): 567-604 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| Multi-centered, double-blind studies were performed to investigate the clinical utility of alacepril (25-50mg in 2 divided doses a day) versus captopril (37.5-75mg in 3 divided doses a day), as a reference drug, in essential hypertensive patients under insufficient control of the blood pressure with thiazide-treatment, adopting nationwide 133 facilities. Among the 112 patients and 105 patients administered alacepril and captopril, 98 and 92 were analyzed, respectively. 1) Antihypertensive efficay rates as assessed marked fall plus fall in alacepril and captopril groups were 59.2% and 70.7% by the attending physicians, while 57.1% and 68.5% by the protocol committee, respectively. No significant difference between two groups was observed by the protocol committee, whereas significant one was found in the U test by the attending physicians (p<0.05). 2) Both in alacopril and captopril groups, significant falls in systolic, diastolic and mean blood pressures from the baseline values (initial placebo period) were observed two weeks after treatment and kept through 12 weeks (p<0.001). There was no significant difference in these blood pressure falls between two groups. 3) The incidences of adverse reactions were 12.2% in alacepril group and 14.1% in captopril group, being similar in two groups without any significant difference. The numbers of the adverse reactions occurred accounted for 18 in alacepril group while 24 in captopril group, and thereby drug treatment was discontinued in 2 patients of alacepril group while 4 patients of captopril group, with all being recovered after discontinuation. 4) Utility rates as assessed very useful plus useful by the attending physicians were 64.3% in alacepril group and 71.7% in captopril group, while those by the protocol committee were 51.0% and 67.4%, respectively. For these utility rates, no significant difference was found between two groups by the attending physicians, whereas significant one was found by the protocol committee (p<0.05). The above results, together with taking convenient twice-a-day dosing regimen into account, can be considered to indicate that alacepril is equal to captopril in utility for the treatment of essential hypertensive patients under insufficient control of the blood pressure with thiazide-diuretics medication. (author abst.) | ||
| Keywords | ||
| Alacepril, DU-1219, Double-Blind Study, Combination Therapy, Antihypertensive Diuretics, Essential Hypertension | ||
| Serial number | ||
| JRCT86W2227E008 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Nojunkan Taisha Kaizenyaku no Yoho, Yoryo Settei ni Tsuite no Kangaekata to Mondaiten (Consierations and Problems in Setting the Dosage Regimen of Cerebral Circulation and Metabolism-Improving Agents (Cerebrovascular Disease Remedies)) | ||
| Authors | ||
| OTOMO Eiichi | ||
| Institutional affiliation of first author | ||
| Yokufukai Geriatric Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(5): 649-673 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| (under construction) | ||
| Keywords | ||
| (under construction) | ||
| Serial number | ||
| JRCT86W2227E009 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Randomized Comparison of Low Dose Captopril in Mild to Moderate Essential Hypertension: 25mg Twice Daily vs Three times Daily | ||
| Authors | ||
| KATAYAMA Shigehiro, MARUNO Yoshiko, INABA Munemichi, OMOTO Akira, ITABASHI Akira, ISHII Jun | ||
| Institutional affiliation of first author | ||
| Fourth Department of Internal Medicine, Saitama Medical School | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(5): 735-744 | ||
| Research Design | ||
| CCT | ||
| Abstract | ||
| The antihypertensive effect of the orally active angiotensin-converting enzyme inhibitor-captopril-was retrospectively reviewed in 47 patients with mild to moderate essential hypertension. Captopril, 25mg t.i.d. (n=30), significantly decreased systolic as well as diastolic blood pressure. However, 12.5mg t.i.d. (n=17), resulted in a significant decline only in systolic blood pressure, but not in diastolic blood pressure. We, therefore, tried to compare its hypotensive efficacy at 25mg b.i.d. with 25mg t.i.d. in 18 essential hypertensives utilizing within-patient crossover design. In group I (n=10), 25mg t.i.d. regimen schedule was changed after 8-12 weeks to 25mg b.i.d. for another 8-12 weeks. On the other hand, group II (n=8) started at 25mg b.i.d., went to 25mg t.i.d. after 8-12 weeks and continued during another 8-12 weeks. Blood pressure significantly decreased either at midpoint or endopoint in group I (-23.4(+ -)5.3 -3.7(+ -)4.0 and -27.1(+ -)4.7 -10.5(+ -)3.3) as well as in group II (-12.4(+ -)3.5 -6.4(+ -)2.8 and -20.0(+ -)5.0 -6.1(+ -)2.3). Endpoint blood pressure decline in group I did not differ from that in group I, although one patient in group I showed a blood pressure rise after changing the regimen from 25mg t.i.d. to b.i.d. Plasma renin activity demonstrated a significant increase at 25mg t.i.d. and stayed high even after changing the dosage to 25mg b.i.d. in group I. However, in group II, plasma renin activity rise was not enough to a significant difference throughout the initial 25mg b.i.d. period and the following t.i.d. period. The results suggest that captopril 12.5mg t.i.d. is not enough to decrease diastolic blood pressure, but 25mg b.i.d. demonstrates the same hypotensive efficacy as 25mg t.i.d. Captopril 25mg b.i.d. might be the recommended dosage schedule not only in its hypotensive efficacy but also in its good compliance and quality of life. (author abst.) | ||
| Keywords | ||
| Captopril, Hypertension, Plasma Renin Activity, Compliance, Quality of Life | ||
| Serial number | ||
| JRCT86W2227E010 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Preparation and Pharmaceutical Evaluation for the Long Acting Dosage Form of Captopril (CS-522-R) | ||
| Authors | ||
| NISHIMURA Kenji | ||
| Institutional affiliation of first author | ||
| Product Development Laboratories, Sankyo Co., Ltd. | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(6): 819-826 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| A long acting drug of captopril, captopril retard (CS-522-R) was prepared using a now pharmaceutical technique of forming oily semi-solid matrix (OSSM). In the in vitro dissolution test of CS-522-R, it was confirmed that release of captopril was sustained for 7 hours and that the release velocity is not affected by the intensity of stirring or with the elution solvent. After administration of CS-522-R to dogs, serum levels of it maintained roughly a certain level for approximately 10 hours. In accordance with the serum levels, ACE (angiotensin converting enzyme) inhibition rate and angiotensin-l's antihypertensive effect were also sustained. CS-522-R and the conventional captopril tablets were given to normal persons and the efficacy of this long acting drug was evaluated by using the serum level of captopril as an index. No significant difference in AUC (area under the blood concentration-time curve) was found between the two drugs. The serum level of captopril was sustained longer with CS-522-R than with captopril tablets. (author abst.) | ||
| Keywords | ||
| Captopril-Retard, CS-522-R, Dissolution Test, Blood Levels, ACE Inhibition Rate, Absorption Excretion | ||
| Serial number | ||
| JRCT86W2227E011 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| The Effect of Pre-Anesthetic Cimetidine on Gastric Contents | ||
| Authors | ||
| NOGUCHI Junichi, TAKEDA Junzo, KONISHI Mutsumi, KAWAZOE Taro, YAMAMURA Hideo, INADA Yutaka, KUGIMIYA Toyoki, AMAHA Keisuke, HASHIMOTO Yasuhiko, KOGA Yoshihisa, IKEDA Kazuyuki, MASUDA Tadanori, MASUDA Michiko, MORI Kenjiro, TAMAI Sunao, FUJIMORI Mitsugu, YOSHIMOTO Noritad | ||
| Institutional affiliation of first author | ||
| Department of Anesthesiology, Second Tokyo National Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(7): 963-974 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| The effect of pre-anesthetic cimetidine on gastric fluid pH and volume were studied by double blind comparison. 228 patients who underwent elective surgery under general anesthesia were administered intramuscularly either cimetidine 200mg or placebo at random about one hour before induction of anesthesia. Gastric juice were aspirated four times immediately after tracheal intubation, one hour and two hour after intubation and immediately before extubation. The volume and pH of gastric contents were measured and cimetidine was compared with glucose as placebo. Gastric volume was significantly less and pH was significantly greater in cimetidine treated group than in placebo group at the time immediately after tracheal intubation. No side effect was observed in cimetidine group. Premedication with cimetidine is considered to be useful in the prevention of the aspiration syndrome. (author abst.) | ||
| Keywords | ||
| Cimetidine, Anesthesia, Gastric Fluid, Premedication, Double-Blind Trial | ||
| Serial number | ||
| JRCT86W2227E012 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinicopharmacological Study of Terfenadine, a New Anti-histamic Agent: Safety Study, Pharmacokinetics and Inhibitory Effect on Wheal and Flare induced by Histamin on Normal Volunteers | ||
| Authors | ||
| NAKASHIMA Mitsuyoshi, UEMATSU Toshihiko, TAKIGUCHI Yoshiharu, HASHIMOTO Hisakuni, TEI Ken | ||
| Institutional affiliation of first author | ||
| Department of Pharmacology, Hamamatsu University School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(8): 1063-1079 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| Terfenadine, a new antihistamic agent, was administered to healthy adult volunteers. Its safety and pharmacokinetics were examined. Also studied were its inhibitory effects on wheal and flare induced by histamine at four doses to single dose of Terfenadine. The principal results obtained are summarized as follows: 1) Remarkable abnormalites were not observed in subjective and objective findings upon physical and laboratotory examination. 2) Significant inhibition was not indicated in psychomotor performance tests. 3) Sleepiness, fatigue and lack of concentration were reported as subjective symptoms. 4) The pharmacological action of Terfenadine in blood is thought to be mainly due to Metabolite I. 5) Depending upon the dosage, Terfenadine inhibited wheal and flare induced by the histamine. These results suggest that Terfenadine is a safe antihistamine drug exhibiting few side effects on the central nervous system. (author abst.) | ||
| Keywords | ||
| Terfenadine, Safety, Pharmacokinetics, Histamine Test, Wheal, Flare, Antihistamic Effect | ||
| Serial number | ||
| JRCT86W2227E013 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Effects of SA446 on Essential Hypertension in Single Drug Regimen: Double-blind Clinical Trial v.s. Captopril | ||
| Authors | ||
| IKEDA Masao, IIMURA Osamu, YOSHINAGA Kaoru, KANEKO Yoshihiro, ISHII Masao, SARUTA Takao, YAMADA Kazuo, ITO Keiichi, YAMAMOTO Kenjiro, KOKUBU Tatsuo, ARAKAWA Kikuo, SAKUMA Akira | ||
| Institutional affiliation of first author | ||
| National Cardiovascular Center | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(8): 1081-1116 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| Clinical usefulness of SA446, an angiotensin converting enzyme inhibitor, on essential hypertension was evaluated in comparison with Captopril under a double blind test method. Of 234 cases involved, 11 cases were discarded and the remaining 223 cases were subject to the statistical analysis. 1) In hypotensive effect, SA446 group and Captopril group showed effective rates of 57.3% and 68.6%, respectively by the physician's judgement and 62.5% and 71.3% by the judgement of the Central Committee, and no significant difference were noted between the groups. 2) Side effects were observed in 21 patients (17.2%), 31 cases (25.4%) in SA446 group and in 10 patients (8.9%), 14 cases (12.5%) in Captopril group. No significant difference was noted between the groups in the overall safety judged by the physicians in charge or by the Central Committee. Main complaints observed in SA446 group were eruption (10 cases, 8.2%) and itching (4 cases, 3.3%), while dizziness, dizziness on standing up and light-headed feeling (5 cases, 4.5%) were observed more frequently rather than eruption (3 cases, 2.7%) and itching (2 cases, 1.8%) in Captopril group. 3) In the usefulness judged by the physicians in charge in consideration of hypotensive effect, side effect, improvement of subjective symptoms and results of the clinical laboratory examinations globally, SA446 was judged as "markedly useful" or "useful" for 55.3% of the subjects, while Captopril was judged as useful for 70.3%, showing a significant difference at 5% level. On the other hand, the Central Committee judged SA446 and Captopril useful for 52.2% and 62.5% of the subjects, respectively, and no significant difference was noted between the groups. But, there were more cases in SA446 group for which the drug was judged prohibitive because of suspension of administration due to eruption or itching. The physicians in charge judged the drug prohibitive for 10 cases (9.7%) of SA446 group and 2 cases (2.0%) of Captopril group, while the Central Committee judged the drug prohibitive for 11 cases (12.2%) of SA446 group and 2 cases (2.3%) of Captopril group, and there were significant difference (p<0.05) between the groups in both judgements. There were more cases with eruption by SA446 in the present trial as compared with pilot study or open clinical study of SA446, and the difference of this initial dosage amount might be one of the reasons. In conclusion, SA446 showed an almost equivalent hypotensive effect to Captopril at the initial dose of 15mg day and up to 30mg day, but cased eruption or itching as side effects more frequently than Captopril. On the other hand, dizziness, dizziness on standing up and light-headed feeling were less frequently observed by SA446 than Captopril. (author abst.) | ||
| Keywords | ||
| SA446, Captopril, Essential Hypertension, Double-Blind Study, Single Treatment | ||
| Serial number | ||
| JRCT86W2227E014 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Effects of SA446 on Essential Hypertension in Combination with Thiazide Diuretics: Double-blind Clinical Trial v.s. Captopril | ||
| Authors | ||
| IKEDA Masao, IIMURA Osamu, YOSHINAGA Kaoru, KANEKO Yoshihiro, ISHII Masao, SARUTA Takao, YAMADA Kazuo, ITO Keiichi, YAMAMOTO Kenjiro, KOKUBU Tatsuo, ARAKAWA Kikuo, SAKUMA Akira | ||
| Institutional affiliation of first author | ||
| National Cardiovascular Center | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(8): 1117-1148 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| Clinical usefulness of SA446, an angiotensin converting enzyme inhibitor, in combination with thiazide diuretics was evaluated in patients with essential hypertension whose blood pressure could not be well controlled by the thiazide diuretics. Evaluation was made in comparison with Captopril under a double blind test method. Of 189 cases involved, 8 cases were discarded and the remaining 181 cases were subject to the statistical analysis. 1) In hypotensive effect, SA446 group and Captopril group showed effective rates of 59.1% and 67.5%, respectively by the physician's judgement and 60.5% and 68.0% by the judgement of the Central Committee, and no significant difference were noted between the groups. There were 31 cases (40.8%) in SA446 group and 30 cases (40.0%) in Captopril group whose blood pressure was lowered to less than 149 89mmHg, showing normalization. 2) Side effects were observed in 11 patients (11.6%), 18 cases (18.9%) in SA446 group and in 9 patients (9.6%), 13 cases (13.8%) in Captopril group. No significant difference was noted between the groups in the overall safety judged by the physicians in charge or by the Central Committee. Complaints observed in SA446 group were 3 cases (3.2%) of eruption, 3 cases (3.2%) of itching, 2 cases (2.1%) of palpitation, 2 cases (2.1%) of nausea or vomiting, 1 case (1.1%) of pressure sensation of precordial chest and 7 cases of other symptoms, total 18 cases, while 3 cases (3.2%) of dizziness or dizziness on standing up, 1 case (1.1%) of eruption, 1 case (1.1%) of frequent ventricular extrasystoles, 1 case (1.1%) of epigastric pain and other 7 cases, total 13 cases, were observed in Captopril group. As abnormal change of the clinical laboratory data, 6 cases of increase of GOT and GPT, 4 cases of proteinuria, 3 cases of decrease of WBC and 4 cases of other changes, total 17 cases, were noted in SA446 group, while there were 3 cases of decrease of WBC, 1 case of decrease of RBC, 1 case of proteinuria and 2 cases of other changes, total 7 cases. 3) In the usefulness judged by the physicians in charge in consideration of hypotensive effect, side effect, improvement of subjective symptoms and results of the clinical laboratory examinations globally, SA446 was judged as "markedly useful" or "useful" for 61.4% of the subjects, while Captopril was judged as useful for 72.6%, and no significant difference was noted between the groups. The Central Committee judged SA446 and Captopril useful for 53.8% and 62.8% of the subjects, respectively, and no significant difference was noted between the groups. In conclusion, SA446 showed a satisfactory hypotensive effect in combination with thiazide diuretics on essential hypertension wherein blood pressure could not be controlled enough by thiazide diuretics. SA446 caused no severe side effects and is considered to be a useful antihypertensive. (author abst.) | ||
| Keywords | ||
| SA446, Captopril, Essential Hypertension, Double-Blind study, Combination Treatment | ||
| Serial number | ||
| JRCT86W2227E015 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Evaluation of MN-1695 in Gastric Ulcer | ||
| Authors | ||
| HOSOKAWA Hideaki, SATO Katsumi, KONDO Tetsuo, YAMADA Tetsu, SEKIYAMA Nobuo, TAKASU Shigeya, KATO Hiroshi, INABE Yasujiro, OTA Hidekatsu, NARAZAKI Yoshikazu, YABANA Tsuyoshi, YACHI Akira | ||
| Institutional affiliation of first author | ||
| Department of Gastroenterology, Dokokai Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(8): 1163-1178 | ||
| Research Design | ||
| CCT | ||
| Abstract | ||
| MN-1695, an anti-ulcer drug newly synthesized in Japan, was evaluated for its clinical usefulness in the treatment of 25 patients with gastric ulcer. The results were as follows: 1) To investigate the optimum dose of MN-1695, 13 out of 25 patients were given 4mg, and 12 patients were given 6mg as a daily dose. 2) The healing rate after 8 weeks of treatment was 76.9% in 4mg group, and 50.0% in 6mg group, totaling 64.0%. 3) The healing rate after 8 weeks in the first ulcer cases was 100% in 4mg group, and 80% in 6mg group. 4) There were no adverse reactions nor remarkable changes in labolatory test results. 5) In the global utility rating, utility rate at the level of "useful" or above was 76.9% in 4mg group, and 66.7% in 6mg group, totaling 72.0%. This result is comparable to that of the defensive-factor enhancing drugs already marketed. 6) There was no significant difference between the groups in the endoscopic evaluation after 4 and 8 weeks of treatment, the improvement rating of subjective symptoms and objective findings, the global improvement rating, and the global utility rating. In each evaluation item, the effects in 4mg group tended to be superior, and it is considered due to the difference in the ratio of first ulcer cases and reccured ulcer cases; thus the efficacy and usefulness between doses of 4mg daily and 6mg daily of MN-1695 are nearly equal. From these results, it is concluded that MN-1695 at a dose of 4mg daily has excellent therapeutic effect with high safety as anti-ulcer drug which potentiates defensive factors, and MN-1695 is one of very useful drugs in the treatment of gastric ulcer. (author abst.) | ||
| Keywords | ||
| MN-1695, Gastric Ulcer | ||
| Serial number | ||
| JRCT86W2227E016 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Prophylactic Efficacy of Cimetidine Against Gastric Disturbances Associated with Anti-inflammatory Agents | ||
| Authors | ||
| OZONO Kenji, OCHI Takahiro, ONO Keiro | ||
| Institutional affiliation of first author | ||
| Department of Orthopedic Surgery, Osaka University Medical School | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(8): 1189-1196 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| It is known that patients receiving steroids and non-steroidal anti-inflammatory drugs (NSAID) develop gastric disturbances with a high incidence. To prevent the development of gastric disturbances in such patients, we treated them with cimetidine, a histamine H2-receptor antagonist. Eighty-three patients under treatment with anti-inflammatory agents were given 600mg of cimetidine in three divided doses daily (Cimetidine Group), and their data were compared with those from 87 untreated control patients (Control Group). Results obtained are as follows: 1) Cimetidine prevented the development of gastric disturbances in 77 (92.8%) of the 83 treated cases. 2) The cumulative incidence of gastric symptoms for the Cimetidine Group was 7.4%, which was significantly lower than that for the Control Group, 35.0% (p<0.01). 3) Gastric disturbances frequently observed were heartburn (1.2% for the Cimetidine Group; 26.0% for the Control Group) and nausea (6.3% and 30.0% for the respective groups). Theses symptoms developed earlier in the untreated patients than in the treated ones. 4) None of the patients of either group had severe stomach symptoms. Moderate symptoms were observed in only two cases of the Cimetidine Group, as against 18 cases of the Control Group, which indicates that the severity of symptoms was markedly reduced in the cimetidine-treated patients. 5) There was no significant difference between the groups as to the course of the underlying diseases, suggesting that cimetidine does not affect the underlying diseases in the patients receiving it. (author abst.) | ||
| Keywords | ||
| Cimetidine, Anti-Inflammatory Agent, Prophylaxis Gastric Disturbance | ||
| Serial number | ||
| JRCT86W2227E017 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Determination of the optimal dose of aniracetam tablet in treatment of patients with cerebrovascular diseases: A comparative study between two levels by a non-double blind trial | ||
| Authors | ||
| OTOMO Eiichi, HASEGAWA Kazuo, INANAGA Kazutoyo, NISHIMURA Tsuyoshi, HIRAI Shunsaku, ARAKI Goro, FURUKAWA Tatsuo | ||
| Institutional affiliation of first author | ||
| Department of Internal Medicine, Yokufukai Geriatric Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(9): 1239-1267 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| For the purpose of studying the efficacy, safety and optimal dose of aniracetam, 2 oral levels were compared with each other in patients with cerebral infarction, intracranial hemorrhage, postapoplectic syndrome and cerebral arterioscrerosis. A non-double blind trial was carried out using 600mg day (111 cases) and 900mg day (107 cases). Aniracetam tablet (100mg) was administered at 200mg t.i.d. (600mg day) or 300mg t.i.d. (900mg day) for 12 weeks in principle. There was no significant difference between the 2 dose groups in the demographic factors of patients. 1) In the comprehensive evaluation, the global improvement rating (GIR) at the final administration for "moderately improved" or better was 22% with 600mg day and 17% with 900mg day while the one for "slightly improved" or better was 73% with 600mg day and 63% with 900mg day. Differences between the 2 dose groups were not significant statistically. The overall safety rating (OSR) for "safe" was 90% with 600mg day and 87% with 900mg day, the difference being not significant. The general usefulness (GU) for "useful" or better was 25% with 600mg day and 24% with 900mg day while the one for "slightly useful" or better was 73% with 600mg day and 63% with 900mg day. The differences were not significant. 2) GIR according to each symptom was rather high with either dose level in mental and subjective symptoms. Items for which 600mg day was significant or tended to be superior to 900mg day were "decreased spontaneity," "nocturnal delirium," "disorientation," "decreased capacity for attention," "general disturbance of intellectual mental functions" and "disturbance of movement." Item for which 900mg day tended to be superior was "anxiety irritability." 3) In the final GIR (FGIR) according to demographic factors, the items for which 600mg day was significantly superior to 900mg day were "overranged EEG," "with rehabilitation" and "with concomitant drugs (cerebral metabolism activators or cerebral circulation improver)." 4) Side effects probably or uncertainly related to the drug occurred in 4.5% with 600mg day and in 1.9% with 900mg day, generally being slight and not severe in any case. Overranged laboratory parameters appeared in 5 cases (7 items) and in 9 cases (17 items), all of which were slight and did not require any treatment. In conclusion, 600mg day and 900mg day of aniracetam did not show any significant difference from each other, but in consideration of a slight betterment in efficacy and safety, 600mg day was decided to be the optimal dose for the treatment of symptoms due to cerebral circulation disorders. (author abst.) | ||
| Keywords | ||
| Aniracetam, Optimal Dose, Cerebrovascular Disease | ||
| Serial number | ||
| JRCT86W2227E018 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Evaluation of Lipo PGE1 on Occupational Vibration Syndrome Using Double-blind Comparative Method | ||
| Authors | ||
| AGISHI Yuko, ASANUMA Yoshihide, SHIMIZU Sada, ISHIKAWA Hiroshi, NISHIHARA Hisashi, NISHIMURA Akio, YOSHIMATSU Toshikazu, OKUBO Koichi, SUZUKI Wataru, KATO Masao, FUKUSHIMA Takeshi, NASU Yoshiro, MATOBA Tsunetaka, YAMADA Koji, MAEDA Saneyuki, KIYONAGA Hiroshi, MIZUSHIMA Y | ||
| Institutional affiliation of first author | ||
| Balneotherapeutic Research Institute, Hokkaido University School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(9): 1269-1289 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| We conducted a double-blind comparative study to evaluate the results of the treatment, safety, and effects of Lipo PGE1 intravenous infusion compared to the control group using PGE1・CD, for occupational vibration syndrome jointly at 15 institutes throughout the country. 1) The study was conducted for inpatients having over grade II conditions based on "Kihatsu" No. 494 (June 28, 1976). The group administered with Lipo PGE1 (L group) consisted of 57 cases, while those administered with PGE1・CD (P group) included 55 cases for a total of 112 cases. The standard used for the usage and dosage of the L group was PGE1 of 10microg day, and for the P group was PGE1 of 40microg day. The amounts were dissolved in the normal saline solution and given to the patients once a day for 90 minutes via intravenous infusion and continued over 2 weeks. 2) In the distribution of global improvement of the subjective symptoms, the L group was noticeably superior to the P group (W: p<0.05). This study demonstrated indications of some cases showing better than "slight improvement", that is, the L group was 87.8% and the P group was 68.8% (x2: p<0.05). 3) As for the global improvement rating on the functional test, better than a slight improvement resulted in 55.6% in the L group and 51.2% in the P group. No significant difference was evident between the two groups, nor was there a significant difference in "the improvement" among 14 of the functional test items. However, the L group was superior to the P group in 9 items. 4) On the final global improvement rating, the cases indicating better than slight improvement were the L group of 85.7% and the P group of 64.6%. The L group was markedly superior to the P group (W: p<0.05, x2: p<0.05). 5) The frequency of side effects was 36.8% for the L group and 58.2% for the P group. Thus the L group was noted significantly smaller than the P group in the frequency. Cases where administration was stopped due to side effects were 10 cases for the L group and 8 cases for the P group. The main symptoms seen in many cases were paroxysmal vasculitis, redishness and venulitis. 6) The study results concerning overall safety rating indicated that the L group was safer at 63.2% to the P group 43.6%, but not significantly so. 7) Concerning the global utility rating, a significant difference was clarified between the two groups, with L group being superior to the P group (W: p<0.05). In those cases which showed better than slight usefulness, L group indicated 71.4% and the P group 55.6%. From the results of the above study, the intravenous infusion of Lipo PGE1 can be considered to be useful in the treatment of occupational vibration syndrome. (author abst.) | ||
| Keywords | ||
| Lipo PGE1, Occupational Vibration Syndrome, Double-Blind Study | ||
| Serial number | ||
| JRCT86W2227E019 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| A Double Blind placebo-controlled Group-comparative Study of DSCG Aerosol in Adult Patients with Bronchial Asthma | ||
| Authors | ||
| SHIDA Takao, MIYAMOTO Terumasa, KISHIMOTO Susumu | ||
| Institutional affiliation of first author | ||
| Clinical Research Center for Allergy and Rheumatology, National Sagamihara Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(9): 1291-1311 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| We investigated the effect, safety and usefulness of DSCG aerosol on bronchial asthma in adults in a multiple center placebo-controlled double-blind group-comparative study and obtained the following results: 1) Of the 176 patients, 136 (71 in the DSCG group and 65 in the placebo group) were analyzed for overall improvement and 40 were excluded. 2) Overall improvement: Improvement inclusive of moderate and marked was 50.7% in the DSCG group and 27.7% in the placebo group; inclusive of slight, the rates were 73.2% and 53.8% respectively. The improvement was significantly higher in the DSCG group than in the placebo group. The fortnightly overall improvement (2nd, 4th and 6th week) was significantly higher in the DSCG group than in the placebo group, and the onset of effect was more rapid in the DSCG group than in the placebo group. 3) Overall safety: Side effects developed in 2.3% of the DSCG group and in 5.7% of the placebo group. There were no statistically significant differences between the DSCG and placebo groups in incidence of side effects. The side effects were all slight: pharyngeal irritation in the DSCG group and trachephony, pharyngeal irritation, headache and nausea in the placebo group. There were no abnormal findings in laboratory tests. 4) Usefulness: The drug was very useful or useful in 47.2% of the DSCG group and in 29.9% of the placebo group, and slightly useful, useful, or very useful in 73.6% of the DSCG group and in 52.2% of the placebo group. The usefulness was significantly higher in the DSCG group than in the placebo group. These findings indicate that DSCG aerosol, 2 puffs, 4 times a day, is potently effective and safe for the treatment of bronchial asthma in adults. (author abst.) | ||
| Keywords | ||
| Sodium Cromoglycate, Aerosol, Bronchial Asthma, Double Blind Study | ||
| Serial number | ||
| JRCT86W2227E020 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Comparison of Clinical Effect on Vegetative Dystonia of Clotiazepam Using Double-blind Technique | ||
| Authors | ||
| TSUTSUI Sueharu, TSUBOI Koji, NAKANO Koichi, TAHARA Keiji, NAKAGAWA Yasuhiro, KATSURA Taisaku, KIKUCHI Takenori, YAMADA Ryonosuke, KAWANO Tomonobu, YAMAOKA Masayuki, NAMBA Tsunehiko, NAGATA Katsutaro, SAITO Toshiji, OSHITA Atsushi, YAMAMOTO Haruyoshi, MATSUZAKI Hiromits | ||
| Institutional affiliation of first author | ||
| Department of Psychosomatic Medicine, Toho University School of Medicine, Omori Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(10): 1395-1411 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| Clinical evaluation of clotiazepam on vegetative dystonia was studied under a double blind test in comparison with inactive placebo. The test drug contained 5mg of clotiazepam in one tablet, and appearance of the test drug and the placebo were same. The patients were received one tablet three times a day for 4 weeks with fixed schedule. The results were as follows: 1) The cases objectived were 180 patients who visited 18 institutes, involved 87 cases with clotiazepam and 93 cases with placebo. Out of these case, 3 cases administered clotiazepam and 12 cases administered placebo were excluded. 2) In the final general improvement rating, clotiazepam group was supperior to control group significantly. The same result was recognized from the data of the central comittee's judgement. 3) As to the overall safety rating, no adverse reaction was found in 81 cases out of 87 cases with clotiazepam and in 91 cases of 93 cases with placebo. 4) For global usefulness rating, clotiazepam group was significantly superior to control group, and the same result was demonstrated by the central comittee's judgement, too. 5) In the stratification analysis on the final general improvement rating by the central comittee's judgement, clotiazepam group was superior in "female" "the cases in thirties" "outpatients" "none of complication" "the case of CMI II" "none of combination drug". 6) In the dermographism excuted as the autonervous function test, the cases improved over than 2 levels tended to be frequent in the group with clotiazepam. 7) As for the improvement of the subjective symptoms, the following items were shown that clotiazepam group was significantly superior to placebo group; "anxiety", "agitation", "tension", "anorexia", "difficulty in falling sleep", "dizziness" "stiffness of shoulder" 8) Side effects were observed drowsiness in 4 cases with clotiazepam, while one gastric disturbance with placebo. All the side effects were mild. From the above results, it is considered that clotiazepam is a useful drug on vegetative dystonia. (author abst.) | ||
| Keywords | ||
| Clotiazepam, Vegetative Dystonia, Double Blind Study, Placebo | ||
| Serial number | ||
| JRCT86W2227E021 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Experience with PJ-185S (Loperamide Hydrochloride Fine Granules) | ||
| Authors | ||
| MAEDA Kazuichi, URYU Tsutomu, KINOSHITA Michiko, SHINOZAWA Takashi, TOCHIGI Ryotaro, HAGISAWA Hiroshi | ||
| Institutional affiliation of first author | ||
| Department of Pediatrics, Saitama Medical School | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(10): 1413-1433 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| Loperamide hydrochloride 0.05% fine granule was administered in a daily dose of 0.01-0.08mg kg for an average of 3.8 days to 31 patients with acute gastroenteritis mainly accompanied by watery stools, 6 with infantile diarrhea and 2 with white diarrhea, or a total of 39 patients to evaluate its efficacy, safety and utility. 1) The mean frequency of bowel movements remarkably decreased from 6.9 times per day before treatment to 2.3-3.3 times per day on day 2 of treatment and thereafter. 2) With regard to the consistency of stools, 3-to 4-day treatment resulted in normal stools in 41.0% of the cases. 3) No side effect was found but constipation occurred in 5 cases (12.8%). 4) In the utility evaluation of this drug, "very useful" ratings were obtained in 59.0% (23 39) and "useful" and higher ratings in 82.0% (32 39). 5) Based on the above-mentioned results, this drug was judged to be an excellent antidiarrheal drug achieving a powerful effect at the dosage of about 0.02mg kg day. (author abst.) | ||
| Keywords | ||
| Loperamide, Infantile Diarrhea, Antidiarrheal Drug | ||
| Serial number | ||
| JRCT86W2227E022 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Study on Safety of Terfenadine: Double Blind Study on Side Effects (Drowsiness and Fatigue) | ||
| Authors | ||
| KUKITA Atsushi, HARADA Shotaro, SHIRATORI Akira, ISHIBASHI Yasumasa, NIIMURA Michito, HIRONE Takae, NOHARA Nozomu, TAKEDA Katsuyuki, YOSHIDA Hikotaro, TASHIRO Masaaki, OGAWA Nobuya | ||
| Institutional affiliation of first author | ||
| Department of Dermatology, National Defense Medical College | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(11): 1549-1558 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| In order to investigate the CNS depressant effect of terfenadine, its incidence of drowsiness and fatigue was studied using the double blind method compared with d-chlorpheniramine sustained-release tablet and placebo in 208 patients with eczema and dermatitis. The incidence of drowsiness and fatigue was 14.3% for terfenadine, 25.7% for d-chlorpheniramine and 13.2% for placebo. (author abst.) | ||
| Keywords | ||
| Terfenadine, Safety Study, Double Blind Study, d-Chlorpheniramine, Placebo | ||
| Serial number | ||
| JRCT86W2227E024 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Results of MD-805, Antithrombin Agent, on Chronic Arterial Occulusion: Multi-center Cooperative Study | ||
| Authors | ||
| TANABE Tatsuzo, MISHIMA Yoshio, FURUKAWA Kinichi, SAKAGUCHI Shukichi, KAMIYA Kisaku, SHIONOYA Shigehiko, KATSUMURA Tatsuki, KUSABA Akira | ||
| Institutional affiliation of first author | ||
| Second Department of Surgery, Hokkaido University | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(12): 1645-1655 | ||
| Research Design | ||
| CCT | ||
| Abstract | ||
| MD-805, antithrombin agent, was administered intravenously in the regimen of 20mg or 40mg daily to 64 cases of chronic arterial occulusion with ischemic ulcer in order to evaluate on it's efficacy, safety and optimal dose. The following results were obtained. 1) The high efficacies were recognized for the general improvement rating and the improvement of ulcer by photograph's judgement of the evaluation committee in the both groups. 2) MD-805 made the size of ulcer reduce remarkably, and showed early effectiveness for the condition of granulation and pain. For the feeling of cool, the drug was effective but the efficacy was inferior to the effects on the ulcer and pain. 3) As to the incidence of side effects and the abnormality of clinical laboratory tests, there was no significant difference between 20mg group and 40mg group, but the side effcts associated with the drug and the cases discontinued the drug were observed frequently in 40mg group. 4) The utility rating was 71% in 20mg group and 59% in 40mg group respectively. 5) It was considered that the above utility of MD-805 seem to be more effective compared with ticlopidine, antiplatelet agent and the high dose of PGE1, vasodilative agent. 6) It was concluded that MD-805 was an effective drug on chronic arterial occulusion and the optimal dose was 20mg daily. (author abst.) | ||
| Keywords | ||
| MD-805, Argipidine, Chronic Arterial Occulusion, Optimal Dose | ||
| Serial number | ||
| JRCT86W2227E025 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| A Group Comparative Double-blind Trial of Nilvadipine with Nifedipine in the Treatment of Angina Pectoris in a Multicenter Cooperation | ||
| Authors | ||
| NAKAMURA Yoshiro, MIYASHITA Hideo, IIMURA Osamu, KAJIWARA Nagao, KISHIDA Hiroshi, TAKAHASHI Nobumitsu, TOYAMA Seiichi, TAKEDA Tadanao, SAKUMA Akira | ||
| Institutional affiliation of first author | ||
| Cardiopulmonary Division, Department of Medicine, Keio University School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(12): 1657-1676 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| Nilvadipine (NV), a new calcium channel blocking agent, was compared with nifedipine (NF) regarding its clinical efficacy in 108 patients with angina of effort, of effort and at rest or at rest using a double-blind manner. The dosage regimens were 4mg t. i. d. for nilvadipine and 10mg t. i. d. for nifedipine. 1) The improvement rate of anginal symptoms was 50.0% (17 34) in the NV group and 67.6% (23 34) in the NF group, and a significant difference was seen between the two groups (P<0.05). However the ordered categorical multiple regression analysis was made to correct the background deviations, and the difference became smaller. 2) The improvement rate of the resting EKG findings was 43.8% (7 16) in the NV group and 50.0% (10 20) in the NF group and no significant difference was seen between the two groups. With respect to the post-exercise EKG findings, the improvement rate was 58.8% (20 34) in the NV group and 65.7% (23 35) in the NF group, and no significant difference was seen between the two groups. 3) The global improvement rate was 58.8% (20 34) in the NV group and 67.6% (23 34) in the NF group, and no significant was seen between the two groups. 4) Side effects or abnormal laboratory findings were seen 6.8% (3 44) in the NV group and 2.0% (1 50) in the NF group, and no significant difference was seen between the two groups. 5) The improvement rate of global utility was 56.3% (18 32) in the NV group and 63.6% (21 33) in the NF group, and no significant difference was seen between the two groups. (author abst.) | ||
| Keywords | ||
| Nilvadipine, Calcium Channel Blocking Agent, Angina Pectoris, Double-Blind Trial, Nifedipine | ||
| Serial number | ||
| JRCT86W2227E026 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Loperamide HC1 Fine Granules (PJ-185S) in Acute Diarrhoea of Infants and Children | ||
| Authors | ||
| SUGA Kazuhiro, NAKAO Toru, YOSHIMURA Hideatsu, ABO Wataru, MINAGAWA Kimio, MOTOYA Hisashi, AGATSUMA Yoshitaka, HORINO Kiyotaka | ||
| Institutional affiliation of first author | ||
| Department of Pediatrics, Sapporo Medical University | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1986; 2(12): 1677-1685 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| Loperamide hydrochloride was administered in daily doses of 0.01, 0.02, 0.04 and 0.08mg kg to 45 infants and children with acute diarrhoea and the following results were obtained. 1) The drug was very useful at all dose levels, and there was no statistically significant difference in efficacy among doses. 2) Clinically significant side effect originating in this drug was not found, so it was considered that the drug was highly safe. 3) Laboratory examination showed slightly elevation of serum transaminase in a few cases. However, the causal relation to the drug was unknown. 4) The blood concentration of the drug was extremely low, therefor it was suspected that the drug was little transferred into the circulatory system. 5) The appropriate dose of this drug was considered to be 0.01 to 0.04mg kg day. (author abst.) | ||
| Keywords | ||
| Loperamide HCl, PJ-185S, Acute Diarrhoea | ||
| Serial number | ||
| JRCT86W2227E027 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Evaluation of the Antihypertensive Efficacy and Usefulness of Long-acting Captopril (CS-522-R) in Monotherapy for Essential Hypertension: A Multicenter Double-blind Comparative Study using Conventional Captopril as a Control Agent | ||
| Authors | ||
| KANEKO Yoshihiro, ISHII Masao, IIMURA Osamu, YOSHINAGA Kaoru, KURAMOTO Kizuku, YAMADA Kazuo, IKEDA Masao, KUMAHARA Yuichi, KOKUBU Tatsuo, OMAE Teruo, ARAKAWA Kikuo | ||
| Institutional affiliation of first author | ||
| Second Department of Internal Medicine, Yokohama City University School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(1): 21-63 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| The antihypertensive efficacy of long-acting captopril (CS-522-R) in monotherapy for mild to moderate essential hypertension was compared with that of conventional captopril in a multicenter double-blind study. Following a 4-week placebo period, patients (30 to 69 years old) were randomized to treatment with CS-522-R, 18.75mg two time daily, or captopril, 12.5mg three times daily, for 4 weeks. If a satisfactory response was not achieved, the dose was doubled and the treatment was continued for 12 weeks in total. The results of the study are as follows: 1) One hundred and thirty-seven patients were given CS-522-R and 134 given captopril. However, 10 patients and 13 patients from the CS-522-R and the captopril groups, respectively, were excluded from analysis for the antihypertensive effect because of short placebo periods or inadequate clinical backgrounds. Thus, 127 patients of the CS-522-R and 121 patients of the captopril groups were analyzed for the antihypertensive effect. 2) Decreases in systolic, diastolic and mean blood pressures were all significant as early as 2 weeks after starting the treatment, and the reduction in blood pressure tended to be strengthened as the treatment was continued. If the patients who finally show a reduction in mean blood pressure of 13 mmHg or more are defined as responders, the responder rate was 65% in the CS-522-R and 58% in the captopril groups according to the evaluation by the doctors in charge, and 57% in the CS-522-R and 55% in the captopril groups according to the evaluation by the executive committee. There was no significant group difference with either evaluation. 3) According to the doctors in charge, subjective symptoms were judged to have been improved in 68% of the patients, who had been positive for these in the placebo period, in the CS-522-R group, and in 53% in the captopril group. The group difference in an improving rate was not significant. 4) When based on the evaluation by the doctors in charge, the occurrence of side effect was 11.8% in the CS-522-R and 7.0% in the captoptril groups. When analyzed by the executive committee, the occurrence of moderate to serious side effects was 11.8% in the CS-522-R and 7.0% in the captopril groups. Dropouts due to side effects were 4 (2.9%) in the CS-522-R and 3 (2.3%) in the captopril groups. There was no significant difference in occurrence of side effects with the evaluation by the doctors or by the executive committee. 5) When the antihypertensive effect, the effects on subjective symptoms and the occurrence of side effects including abnormal laboratory findings were taken together, CS-522-R was considered to be "useful" in 63% and captopril in 58% of the treated patients on the basis of the evaluation by the doctors. According to the evaluation by the executive committee, CS-522-R was "useful" in 50% and captopril in 52% of the treated patients. There was no significant group difference with either evluation as well. 6) The results were not biased when all of the 137 patients given CS-522-R and 132 patients given captopril were included for the above analyses. These findings indicate that the antihypertensive efficacy and usefulness of a daily dose of 37.5 to 75mg of CS-522-R in two divided doses are not significantly different from those of the same daily dose of captopril in three divided doses in patients with mild to moderate essential hypertension. (author abst.) | ||
| Keywords | ||
| Essential Hypertension, Antihypertensive Monotherapy, CS-522-R, Captopril | ||
| Serial number | ||
| JRCT87W2227E001 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| A Study on the Clinical Utility of Alclometasone Dipropionate (S-3460) Ointment: A Bilateral-paired Comparison Study on Oozing Eczema-Dermatitis, Lichenified Eczema-Dermatitis, Psoriasis, Acute Prurigo and Subacute・Chronic Prurigo | ||
| Authors | ||
| ISHIBASHI Yasumasa, HARADA Syotaro, KUKITA Atsushi, ISHIHARA Masaru, NIIMURA Michihito, TAMAKI Kunihiko, OKAWARA Akira, TAKAHASHI Makoto, TAGAMI Hachiro, KAGAWA Saburo, NISHIKAWA Takeji, HONDA Mitsuyoshi, TODA Kiyoshi, OHARA Kuniaki, SASAKI Tetsuo, TOMIZAWA Takanori, HOR | ||
| Institutional affiliation of first author | ||
| Department of Dermatology, Faculty of Medicine , University of Tokyo | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(1): 65-88 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| In order to compare the clinical utility of 0.1% alclometasone dipropionate (ADP) ointment and 0.1% hydrocortisone butyrate (HCB) ointment on oozing eczema-dermatitis, lichenified eczema-dermatitis, psoriasis, acute prurigo and subacute & chronic prurigo, a bilateral-paired comparison study was conducted by 30 institutions. The results were as follows. 1) A total of 226 cases were analyzed for efficacy and 227 cases for safety. 2) In subacute and chronic prurigo, ADP ointment decreased the severity of papule and nodule significantly much more than HCB ointment after 2 weeks of treatment. 3) ADP ointment was useful in 69.6% of oozing eczema-dermatitis, 78.3% of lichenified eczema-dermatitis, 43.9% of psoriasis, 58.3% of acute prurigo and 72.4% of subacute and chronic prurigo. 4) Side effects of ADP ointment were observed in 7 cases (3.1%) as follows: folliculitis, steroid erythema, telangiectasia, steroid purpura and skin atrophy. All of them were minor in nature. (author abst.) | ||
| Keywords | ||
| Alclometasone Dipropionate, Dermatoses, Bilateral-Paired Comparison Study, Clinical Utility | ||
| Serial number | ||
| JRCT87W2227E002 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Comparison of Antianginal Effects of Nilvadipine (FK235) and Diltiazem in Patients with Exertional Angina: A Multicenter Double-Blind Crossover Trial | ||
| Authors | ||
| KATO Kazuzo, TAKAHASHI Nobumitsu, MURAYAMA Masahiro, MOTOMIYA Takeshi | ||
| Institutional affiliation of first author | ||
| Cardiovascular Institute Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(1): 105-132 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| The efficacy and usefulness, especially the effects on exercise tolerance, of nilvadipine (FK235), a calcium channel blocking agent, and diltiazem were compared in 33 patients with angina of effort or both angina of effort and at rest, using a double-blind crossover study design. The study consisted of an initial 1-2-week, single-blind placebo control phase, followed by two 2-week double-blind phases that included randomization to nilvadipine (4mg t.i.d.) or diltiazem (30mg t.i.d.) and crossover. Treadmill exercise tests were performed on the final day of each of the three phases. The results obtained were as follows: 1) Exercise performance was improved moderately or markedly in 70.0 percent of patients with nilvadipine and 45.0 percent with diltiazem. Although no statistically significant differences were noticed between nilvadipine and diltiazem within the individual patients, nilvadipine tended to be superior to diltiazem in improving exercise performance moderately or more, when analysed by McNemar's test. 2) In patients who had chest pain and 1 mm or more of ST-segment depression during the control exercise tests, the time to onset of pain, total exercise time and time to 1 mm of ST-segement depression were significantly increased during both treatment (nilvadipine and diltiazem) phases compared with the control phase. There were no significant differences between nilvadipine and diltiazem in any of these parameters. 3) The magnitude of ST-segment depression was decreased by both nilvadipine and diltiazem not only at the identical exercise time to the total exercise duration in the control phase but at peak exercise. However, the rate-pressure products at peak exercise did not change significantly with either drug. These results were thought to suggest nilvadipine and diltiazem increased exercise tolerance by reducing the increase in myocardial oxygen consumption during exercise as well as by increasing coronary blood flow to ischemic myocardial region. 4) Three episodes of nocturia, heavy-headedness and gastro-intestinal malaise were noted in three patients who received nilvadipine and 6 episodes of itching, rash, tibial edema, headache and exahaution were noted in three patients during diltiazem treatment. No significant abnormalities were observed in laboratory examinations. It was concluded that nilvadipine 4mg t.i.d. has similar effect to diltiazem 30mg t.i.d. in improving exercise tolerance in patients with exertional angina. (author abst.) | ||
| Keywords | ||
| Nilvadipine (FK235), Diltiazem, Angina Pectoris, Exercise Time, Time to 1mm of ST-Segment Depression | ||
| Serial number | ||
| JRCT87W2227E003 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Evaluation of MN-1695 [2,4-diamino-6-(2,5-dichlorophenyl)-s-triazine maleate] on Gastric Ulcer: A Multicenter, Group-comparative Double Blind Study with Gefarnate | ||
| Authors | ||
| TAKINO Tatsuro, KODAMA Tadashi, OKANO Hitoshi, OGAWARA Yasuo, SHIMONO Michihiro, KADOTANI Hitoshi, BAMBA Michio, YAMASHITA Shigeo, FUKUDA Shinichiro, NAKAI Tetsuro, DEGUCHI Takeshi, TAKADA Hiroshi, KIZU Minoru, NAITO Eiji, TAKANASHI Tadahiro, NISHIDA Kazuhiro, SATO Tatsu | ||
| Institutional affiliation of first author | ||
| Department of Internal Medicine 3, Kyoto Prefectural University of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(2): 199-228 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| The clinical efficacy, safety and utility of MN-1695 on gastic ulcer were compared with gefarnate in a double blind study. The dosage regimens were 4mg a day (in the morning) for MN-1695 (M-group) and 300mg a day (divided to 3 times) for gefarnate (G-group). They were given for 8 weeks in principle. 1) 131 patients participated in this study (M-group: 67, G-group: 64). No Significant difference was found in patients' backgrounds between the two groups after the unsuitable cases were excluded for analysis. (M-group: 62, G-group: 59) 2) For the judgement by the endoscopic examination at the 4th week, the reductive rates of the ulcer of "moderate and more than moderate including healing" were 83.3% and 63.0% in the M-group and G-group, respectively, demonstrating a significant difference between the M and G groups. 3) On the endoscopic evaluation at the 8th week, the M-group was superior to the G-group. The healing rates were 66.7% in the M-group and 45.1% in the G-group, and the former was significantly superior to the later. 4) As to the subjective objective symptoms, the improvement rates of "moderate and more than moderate" were 68.5% in the M-group and 63.5% in the G-group, and there was no significant difference between the two groups. 5) The global improvement rates of "moderate and more than moderate" were 84.2% and 70.6% in the M-group and G-group, respectively, and no significant difference was seen between the two groups. 6) Side effects were reported in 2 cases (nausea vomiting and obstipation) in the M-group and 3 cases (unwellness of the abdominal, slight increasing of LDH and obstipation) in the G-group. 7) The utility rates of "useful and more than useful" were 84.2% in the M-group and 65.4% in the G-group. The M-group was significantly superior to the G-group. Based on the above results, it was concluded that MN-1695 was effective for accelerating of the healing of gastric ulcer in once daily dosage regimen and a safe and useful drug for the treatment of gastric ulcer. (author abst.) | ||
| Keywords | ||
| MN-1695, Gefarnate, Gastric Ulcer, Double Blind Study | ||
| Serial number | ||
| JRCT87W2227E004 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Evaluation of Propafenone (YM-13400) in Patients with Premature Ventricular Contraction: A Multicentered Double Blind Study with Disopyramide | ||
| Authors | ||
| KATO Kazuzo, IINUMA Hiroyuki, HAYAKAWA Hirokazu, KATO Takao, SUGIMOTO Tsuneaki, MATSUO Hiroshi, HIEJIMA Kazumasa, KASANUKI Hiroshi, TANABE Akihisa, SHIMIZU Naohiro, KAMEYAMA Masakuni | ||
| Institutional affiliation of first author | ||
| Cardiovascular Institute Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(8): 969-990 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| A double-blind, parallel study of the efficacy and safety of propafenone was conducted as compared with disopyramide as treatment for premature ventricular contraction (PVC) in 41 centers. The study consisted of a 2-7 day run-in phase (observation phase) followed by a 2-week, double-blind, parallel phase during which patients received either propafenone (450mg day, t.i.d.) or disopyramide (300mg day, t.i.d.). Twenty-four hours Holter recordings were made before and 2 weeks after the treatment to determine efficacy. The results were summarized as follows: 1) Of 168 patients studied, 84 received propafenone and 84 did disopyramide. There were no significant differences in the background data of patients between the 2 groups except for a lager number of inpatients in the propafenone group. 2) In terms of the subjective symptoms, number of PVC and overall improvement rate, 54, 74% and 74% of the propafenone group and 31, 50 and 48% of the disopyramide group were evaluated as being improved moderately and over, respectively. Propafenone was significantly superior to disopyramide in all of the 3 efficacy parameters described above. 3) Both propafenone and disopyramide significantly reduced the number of VPC from the baseline level. The mean percentage reduction was 52.3% in the propafenone group and 30.2% in disopyramide group. In the propafenone group, PVC decreased by 90% or more in 31% of the patients, by 75 to 90% in 18%, and 50 to 75% in 19%. The corresponding values for the disopyramide group were 23, 7 and 19%. There were significant differences between the propafenone and disopyramide groups in reducing the number of PVC. In addition, both drugs improved Lown's grade but there were no significant differences between 2 groups. 4) Adverse reactions developed in 6 of the 84 patients receiving propafenone, and 21 of the 84 receiving disopyramide. Abnormal variation in clinical laboratory tests was detected in 6 of the propafenone group, and 5 of the disopyramide group. In terms of the overall safety, propafenone was significantly superior to disopyramide. 5) In terms of the overall clinical utility, propafenone (68%) was significantly superior to disopyramide (35%). In conclusion, propafenone was shown to be a very useful drug in treatment of PVC. (author abst.) | ||
| Keywords | ||
| Propafenone, Disopyramide, Premature Ventricular Contraction, Double Blind Study | ||
| Serial number | ||
| JRCT87W2227E005 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Evaluation of LM-001 in the Treatment of Ureteral Colic: A Double-Blind Comparative Study with Pentazocine | ||
| Authors | ||
| ORIGASA Seiichi, KUWAHARA Masaaki, HOSHI Senji, KAGEYAMA Shizuichi, NAKANO Nobumichi, ONUMA Tetsutaro, MATSUDA Shotaro, IMAI Yoshitada, KATO Masakazu, KUJI Satoru, KUROSAWA Masaya, SUGAWARA Keiji, KIMURA Shoichi, KONDA Ryuichiro, ARAI Motoyoshi, CHIBA Ryuichi, TOCHIGI Ta | ||
| Institutional affiliation of first author | ||
| Department of Urology, Tohoku University School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(8): 991-1010 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| A multicenter double-blind comparative study of LM-001 (LM), i.v. agent of non-steroidal felbinac ethyl having potent inhibitory activity for prostaglandin synthesis was carried out in comparison with pentazocine (PZ) as a control to evaluate the usefulness of LM in the treatment of patients with acute attacks of ureteral colic. A total of 76 cases (37 cases in LM group and 39 cases in PZ group) were assessed for efficacy, tolerance and usefulness. Overall improvement rate evaluated as “good" or “exellent" was 94.6% for the LM group and 71.8% for the PZ group, showing significant difference between the two groups (p<0.05, Fisher's exact test). The onset time of pain relief in the LM group tended to show swifter than that of the PZ group (p<0.10, U test). The mean duration of relieving effect on pain was 17.2 hours for the LM group and 15.8 hours for the PZ group, with no significant difference between the two groups. As regards side effects, body heat sensation with head heaviness was found in one case of the LM group and nausea with vomiting in one case of the PZ group. In no case the side effects were serious and the frequency did not differ significantly between the two groups. Abnormal laboratory findings, i.e. slight elevation of GPT was noted in one case of the PZ group, and no changes attributable to treatment were noted in the LM group. From the above mentioned results, we conclude that LM-001 is more useful than pentazocine for the treatment of patients with acute attacks of ureteral colic. (author abst.) | ||
| Keywords | ||
| LM-001, Felbinac Ethyl, Prostaglandin Synthetase Inhibitor, Double Blind Comparative Study, Ureteral Colic | ||
| Serial number | ||
| JRCT87W2227E006 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Dose finding study of Aciclovir tablet for Herpes simplex virus infection | ||
| Authors | ||
| NIIMURA Michihito, OKAWARA Akira, FUKAYA Toru, TAGAMI Hachiro, TOMITA Yasushi, HONDA Mariko, ISHIBASHI Yasumasa, FURUE Masutaka, NISHIKAWA Takeji, MASUDA Mistugi, HAYAKAWA Kazuhito, MIZOGUCHI Masako, HORIKAWA Etsuo, HIDANO Akira, HAYASHI Yoko, HORI Yoshiaki, NAKABAYASHI | ||
| Institutional affiliation of first author | ||
| Department of Dermatology, Jikei University School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(4): 337-350 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| The dose finding study of ACV tablet was conducted in patients with herpes simplex virus infection (eczema herpeticum, initial genital herpes, etc.) at dosages of 100mg, 200mg and 400mg five times daily by "envelope method". The total number of subjects treated with ACV tablet was 78. The numbers used for analysis were 21 cases in 100mg group, 21 cases in 200mg group and 23 cases in 400mg group. The results were as follows; 1) ACV tablet was very effective in the three dosage groups. A significant difference was not seen in effectiveness and usefulness. 2) As far as patients who suffered from disseminated rash such as eczema herpeticum were concerned, the highly effective rate in 200mg and 400mg dosage groups were 41.2% and 40.0% respectively, but it was only 17.6% in 100mg dosage group. 3) A further significant difference was found in general improvement on day 4(t-test, alpha=0.10) between 100mg and 200mg groups. 4) The times to disappearance of virus were 3.58(+ -)1.19 days, 3.86(+ -)1.41 days and 4.00(+ -)1.52 days for 100mg, 200mg and 400mg groups respectively. A significant difference was not observed. 5) The blood concentration of ACV was assayed. The ranges of trough and peak measurements were 0.18-1.35microM, 0.73-4.36microM and 2.44-7.12microM for 100mg, 200mg and 400mg dosage groups respectively. There was apprehension that growth of strains in some patients might not be inhibited at dosage of 100mg five times daily in respect to the sensitivity of ACV against HSV. 6) Side effects and abnormal laboratory tests were seen in 7 of 78 cases (9.0%). No significant differences were found in the three groups. 7) It was concluded that the standard dosage for Japanese patients was 200mg five times daily. (author abst.) | ||
| Keywords | ||
| Aciclovir, Herpes Simplex Virus, Dose Finding Study | ||
| Serial number | ||
| JRCT87W2227E007 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Evaluation of Diclofenac Sodium Suppository in Lumbago: Double Blind Comparative Study with Diclofenac Sodium Tablet | ||
| Authors | ||
| ONO Keiro, OCHI Takahiro, YONENOBU Kazuo, INOKI Reizo | ||
| Institutional affiliation of first author | ||
| Department of Orthopaedic Surgery, Osaka University Medical School | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(5): 561-579 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| The therapeutic usefulness of diclofenac sodium suppository (SUP) 100mg day in lumbago was compared with diclofenac sodium tablet (TAB) 100mg day by a double-blind method, and the result are described below: 1) Out of 209 cases, 151 cases (81 cases in SUP group and 70 cases in TAB group) were assessed for efficacy and 192 cases (101 cases in SUP group and 91 cases in TAB group) were assessed for tolerability and usefulness. 2) In final global improvement ratings, SUP group showed a 38.3% "markedly improved" and a 70.4% "moderately improved" and above. TAB group showed 35.7% and 68.6%, respectively. There is non-significant difference between the two groups. 3) In overall safety ratings ("Safe": 83.2% in SUP group and 81.3% in TAB group), equal safety was observed between the two groups. Furthermore, most of the side-effects were gastrointestinal disorders (13 21 in SUP group and 18 21 in TAB group). As compared with TAB group, however, the incidence in SUP group was slightly less. 4) In global usefulness ratings, SUP group showed a 26.7% "markedly useful" and 65.3% "moderately useful" and above. TAB group showed 30.8% and 61.5%, respectively. There is non-significant difference between the two groups. From the above results, it has been considered that diclofenac sodium suppository is a useful drug in lumbago. (author abst.) | ||
| Keywords | ||
| Double Blind Comparative Study, Diclofenac Sodium Suppository, Lumbago | ||
| Serial number | ||
| JRCT87W2227E008 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Evaluation of AD-1590 in Fever due to Chronic Diseases | ||
| Authors | ||
| HOMMA Mitsuo, ICHIKAWA Yoichi, YOSHIDA Tadashi, SHINOZAWA Taeko, FUJIMORI Ippei, TOMII Masakuni, SAITO Eizo, OSHIMA Hisaji, KATO Keiko, SUZUKI Takahiro, KAWAGOE Mitsuhiro, HARA Masako, HAYAKAWA Masakatsu | ||
| Institutional affiliation of first author | ||
| Keio University Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(6): 721-736 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| The antipyretic effect and safety of AD-1590 in a dose of 10mg (D1) and 20mg (D2) were studied in the management of fever due to chronic diseases, mainly collagen diseases, in three phases, i.e. open study, comparative study using the envelope method, and double-blind placebo (PL)-controlled study. 1) The number of cases analyzed were 16 (D1 group, 4; D2 group, 12) in the open study, 20 (D1 group, 9; D2 group, 11) in the comparative study by the envelope method, and 27 (D1 group, 7; D2 group, 9; PL group, 11) in the double-blind study. 2) The mean body temperature fell immediately after the first dose in both D1 and D2 groups and reached a minimum, substantially afebrile condition, in 3 to 4 hours. In the double-blind controlled study, both D1 and D2 groups showed significantly lower values than the PL group but no difference was found between the D1 group and the D2 group. 3) The antipyretic effect at a draft was similar in D1 and D2 groups. In the double-blind controlled study, the D1 group was significantly superior to the PL group and the D2 group tended to be superior to the PL group. In overall evaluation, D1 and D2 groups showed similar results. 4) No side effect was found. Clinical laboratory tests showed no drug-related abnormal change, either. 5) The above results suggest that AD-1590 at the doses of 10 and 20mg is superior in antipyretic efficacy to placebo, without any difference between the two doses, and is a useful and highly safe drug for the management of fever due to collagen diseases or the like. (author abst.) | ||
| Keywords | ||
| Collagen Disease, Fever, AD-1590, Antipyretic Effect | ||
| Serial number | ||
| JRCT87W2227E009 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Phase I Study of the Antiallergic Agent Sm 857 | ||
| Authors | ||
| KOTANI Keizo, CHINEN Ryosuke, OTANI Masahiro, KONISHI Koichi, KAGIMURA Tatsuo, KOTANI Yasuyuki, HAYASE Shigeru, IMASATO Yoshio, NAGAKURA Akihito, KOBAYASHI Shoji, KOHEI Hiroshi | ||
| Institutional affiliation of first author | ||
| Department of Internal Medicine, Ikeda Kaisei Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(7): 847-870 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| 1) Pharmacokinetics and tolerance of Sm 857 were studied in a total of 48 healthy male adults. 2) The subjects were divided into groups consisting of 6 persons each. Single dose each of Sm 857 placebo tablet, 50mg of Sm 857, 100mg, 200mg, 400mg and 600mg was assigned to each group. One in the placebo group complained of a slight light-headedness 1-2 hours after the dosing, and one in the 200mg administered group, slight nasal stiffness 23-24 hours after. Other subjective symptoms and abnormal objective symptoms such as skin changes were not observed in any groups. 3) Changes attributable to this drugs were not observed in blood pressure, pulse rate, respiratory rate, body temperature, ECG, pulmonary function, visual acuity, audition, anxiety test, and laboratory findings. 4) Sm 857 100mg tablet (t.i.d., 300mg day) and 200mg tablet (t.i.d., 600mg day) were respectively assigned to two groups consisting of 6 subjects each. Both tablets were administered t.i.d. for consecutive 6 days (on Day 6, both tablets were administered twice a day; morning and noon dosings). One subject receiving 300mg day of Sm 857 complained of slight fatigue at night on Day 4, and one receiving 600mg day, loose passage in the morning of Day 5. No other subjects complained of subjective symptoms. No abnormal objective symptoms such as skin changes were observed. 5) In multiple dose study, changes attributable to this drug were not observed in blood pressure, pulse rate, respiratory rate, body temperature, ECG, pulmonary function, visual acuity, audition, anxiety test, and laboratory findings. 6) After single dosing, the plasma concentration of Sm 857 peaked 2-3 hours after the dosing in each dosage, and decreased with a half life of 3-4 hours. The urinary excretion rate of Sm 857 ranged from 27 to 55%. The dosage of Sm 857 significantly correlated with AUC 0-24hr and with urinary excretion rate. 7) During the multiple dosing of Sm 857, an almost constant level of plasma concentration of Sm 857 was maintained from Day 1 through the end of administration in each dosage, which well coincided with the simulation curve based upon the result of single dosing. The urinary excretion rate of Sm 857 ranged from 24 to 38%. 8) Sm 857 tablet was well tolerated up to 600mg in single dosing and 600mg day in multiple dosing for consecutive 6 days. Multiple dosing and dosage of Sm 857 do not seem to influence upon the pharmacokinetic properties of this drug. (author abst.) | ||
| Keywords | ||
| Antiallergic Agent, Sm 857, Phase I Study | ||
| Serial number | ||
| JRCT87W2227E010 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Comparative Study on Antihypertensive Effects as the First Choice Drug for Essential Hypertension of Atenolol and Trichlormethiazide | ||
| Authors | ||
| SUZUKI Makoto, MORI Hisatsune, SAKUMOTO Seiki, KIYUNA Susumu, ASATO Tetsuyoshi, NAKADA Seigo, OSHIRO Yasuhiko, NAGAMINE Fumio, KAWANE Kozo, HIGA Koichi, UEHARA Kazuhiro, FUJIMOTO Katsuyoshi | ||
| Institutional affiliation of first author | ||
| Department of Community Medicine, Ryukyu University Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(8): 1011-1028 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| The utility of atenolol, a beta-blockade, was compared with trichlormethiazide, a diuretic, on outpatients with essential hypertension at 9 hospitals in Okinawa prefecture using the envelope method. The following results were obtained. 1) As for the antihypertensive effects, safty and utility, no significant differences were noted between the two groups. 2) In the group administered 50mg per day of atenolol, significant falls in systolic and diastolic blood pressures in the 1st and 2nd periods were noted. On the other hand, in the group administered 2mg per day of trichlormethiazide, although significant falls in systolic and diastolic blood pressures in the 1st period and in systolic in the 1st and 2nd periods were observed, none were seen in diastolic blood pressure in the 2nd period. 3) A significant decrease in pulse rate was notable in the atenolol group but there were no cases in which drug administration had to be discontinued. 4) The side effects considered to be due to atenolol or to trichlormethiazide were all mild and not serious. 5) No abnormal clinical laboratory findings were noted. In conclusion, the antihypertensive effect of atenolol 50mg per day did not differ from the effect of trichlormethiazide 2mg per day, and the incidences of side effects were low. Therefore, atenolol is considered to be an effective and safe drug for the antihypertensive agent requiring long-term administration, which could replace a diuretic as a drug of the first choice. (author abst.) | ||
| Keywords | ||
| Atenolol, Trichlormethiazide, Antihypertensive Efficacy, Comparative Study | ||
| Serial number | ||
| JRCT87W2227E011 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Evaluation of FM-100 on Acute Gastric Mucosal Lesions: Dose finding study by Double blind Method | ||
| Authors | ||
| SAKITA Takao, MIWA Takeshi, FUKUTOMI Hisayuki, KIMURA Ken, MORI Katsuaki, HATTA Yoshio, TAKEUCHI Tadashi, ABE Masanao, UMEDA Noritsugu, YOSHIYA Kazuo, KANEKO Eizo, NOMURA Kijuro, KAMATA Teisuke, WATANABE Fumitoshi, YAGISHITA Masaya | ||
| Institutional affiliation of first author | ||
| Department of Gastroenterology, Showa General Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(9): 1061-1077 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| The clinical effects of FM-100, widely used as an antiulcer agent, on acute gastric mucosal lesions were compared endoscopically between at a dose of 800mg day and 1600mg day in a double blind method. 1) Fifty eight patients were enrolled and 4 were excluded, thus, 24 patients for the high dose group and 30 patients for the low dose group were analysed. 2) The final global improvement ratings were 54.2 and 75.0% for "markedly improved" and "moderately improved", respectively in the high dose group. On the other hand, in the low dose group, they were 26.7 and 60%, respectively. 3) For the high dose group, endoscopic improvement was obtained in 31.3, 40.0 and 47.8% of patients in week 1, 2 and 4, respectively, and 22.2, 38.5 and 48.1%, respectively for the low dose group. 4) Severe adverse effect was not found in both groups. 5) The usefulness in the high dose group was assessed as very useful or useful in 70.8% of patients, and that in the low dose group was assessed in 56.7% of patients. In conclusion, FM-100 of 1600mg day is considered to be safe and more effective than that of 800mg day for the treatment of acute gastric mucosal lesions. (author abst.) | ||
| Keywords | ||
| FM-100, Acute Gastric Mucosal Lesions, Double Blind Method | ||
| Serial number | ||
| JRCT87W2227E012 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Influence of β-Blocker on Glucose Metabolisms and Cardiovascular Parameters under Insulin-induced Hypoglycemia | ||
| Authors | ||
| KAWANISHI Koichi, UCHIDA Shigeru, KAWASHIMA Koichiro | ||
| Institutional affiliation of first author | ||
| Department of Clinical Laboratory, Kagawa Medical School Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(9): 1123-1134 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| The insulin loading test (loading with 0.05u kg short acting insulin) was performed in 6 normal adults and the effects of atenolol (A group) and carteolol (C group) on metabolism, hormone secretion and hemodynamics in hypoglycemia were investigated. The changes of blood glucose in hypoglycemia were investigated. The changes of blood glucose in hypoglycemia were not different among the control group, A group and C group, but in the C group, a relatively early recovery from hypoglycemia and a tendency of subsequent prolongation of hypoglycemia were found. Concerning the heart rate, the A group showed a decreasing tendency and the C group showed and increasing tendency. The blood concentration of free fatty acids tended to be lower when the drug was administered. The blood glycerol concentration tended to increase on drug administration and was occasionally significantly elevated during the test. The changes in the blood concentration of lactic acid in the A group were not different from those in the control group but the C group showed higher blood lactate levels. The A group showed similar changes in the profile of elimination of insulin from the blood and in the blood concentration of pancreatic glucagon, but the C group showed a delayed elimination of insulin from the blood and a tendency to inhibit hypoglycemia-induced reactions. In the C group, the blood noradrenaline concentration was remarkably low, indicating that carteolol had a potent inhibitory action on noradrenaline secretion. There was no difference in the blood concentration of adrenaline among the control group, A group and C group. The blood cortisol concentration tended to be higher in the A group and the blood concentration of growth hormone was also increased in the A group. In the present study, carteolol exhibited the characteristics shared by non-selective beta-blockers with ISA in hemodynamics, metabolism and hormone secretion, whereas atenolol showed minor differences from control. It seems that atenolol is more advantageous in clinical use when complicated with diabetes. (author abst.) | ||
| Keywords | ||
| Atenolol, Carteolol, Insulin-Induced Hypoglycemia, Hemodynamics, Glucose Metabolism | ||
| Serial number | ||
| JRCT87W2227E013 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Effects of Atenolol and Carteolol on Insulin-induced Hypoglycemia: Symptomatic Characteristics Related to Marked Hypoglycemia | ||
| Authors | ||
| KAWANISHI Koichi, UCHIDA Shigeru, KAWASHIMA Koichiro | ||
| Institutional affiliation of first author | ||
| Department of Clinical Laboratory, Kagawa Medical School Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(9): 1135-1142 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| Atenolol was compared with Carteolol in healthy volunteers who underwent insulin-induced hypoglycemic challenge. This paper emphasizes symptomatic changes observed subjectively and objectively during the hypoglycemic episodes whereas the comprehensive results therefrom have been reported elsewhere. This was a randomized, double-blind cross-over study in which effect of insulin injection in the presence of Atenolol, Carteolol and placebo was compared. Six volunteers entered the study. Each treatment period lasted three days with a two week washout between each period. Subjects administered Carteolol produced substantive increases in both blood pressure and heart rate in 120 minutes after the insulin injection, from those prior to the insulin loading. Although the increases possibly attributable to ISA of Carteolol are significant, when compared with Atenolol, chronological changes in the means appeared relatively constant and comparable with each other. Nevertheless, it behooves to draw a particular attention that one subject who became most hypoglycemic elucidated clearly pharmacological profiles of both of the drugs in that at the trough of the blood glucose level when on Carteolol blood pressure increased while heart rate decreased. By contrast, Atenolol administration to the same individual did not give rise to such phenomena and lead to changes comparable to the placebo control. In spite of the common belief that beta-blockers would mask symptom associated with hypoglycemia profuse sweating was observed in all but one under insulin-induced hypoglycemia. In addition there were propensities that complaints of hunger, drowsiness, general malaise, and lassitude were slightly more prominent under influence of either beta-blocker than in the control. In accordance with the aforementioned it is readily surmised that beta-blockers, above all cardioselective agent like Atenolol could be safely administered to the diabetics without masking hypoglycemic episodes and adversely affecting hemodynamics. (author abst.) | ||
| Keywords | ||
| Atenolol, Carteolol, Insulin-Induced Hypoglycemia, Symptomatic Characteristics | ||
| Serial number | ||
| JRCT87W2227E014 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Effect of Beta Blockers on Asthmatics | ||
| Authors | ||
| MATSUMURA Takayuki, HAYAKAWA Tetsuo, SUKO Matsunobu, MAEDA Yuji, YUI Yasuo, SHIDA Takao | ||
| Institutional affiliation of first author | ||
| Department of Internal Medicine, Clinical Research Center, National Sagamihara Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(9): 1151-1162 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| We have conducted double blind cross-over clinical study in comparing antihypertensive actions as well as effect on pulmonary functions of atenolol 50mg in single dose in comparison with labetalol 100mg in single dose to find as follows; 1) Neither of the drugs reduced FEV1 in two hours after dosing. 2) Bronchodilating actions from inhalation of a beta agonist, salbutamol, was well maintained coupled with significant increase in FEV even under influence of either of the drugs. 3) Atenolol was rated to somewhat exceed in safety due to the following reasons; 1) Reduction of FEV, by more than 10% Atenolol period 5 cases Labetalol period 9 cases 2) Increase in asthmatic symptoms Atenolol period 3 cases Labetalol period 3 cases 4) There existed no difference between the two in terms of such hemodynamic parameters as blood pressure, and heart rate. 5) It is concluded that cardioselective beta-blockers such as atenolol may be administered to asthmatics with due caution (e.g. coadministration of beta agonist) in event that beta-blocker therapies are strongly desired. (author abst.) | ||
| Keywords | ||
| Atenolol, Labetalol, Beta-Blocker, Asthmatics | ||
| Serial number | ||
| JRCT87W2227E015 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| A Paired Comparative Study for Suitable Concentrations of Suprofen Ointment for Eczematous dermatitis | ||
| Authors | ||
| HARADA Shotaro | ||
| Institutional affiliation of first author | ||
| Kanto Teishin Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(10): 1197-1208 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| Paired comparative studies for suitable concentration of suprofen ointment (SP) were carried out on eczematous dermatitis. The efficacy, tolerability and side effects of 1% SP were evaluated in 66 patients with its vehicle (VE) and 70 patients with 2% SP. 1) In global improvement, 1% SP was superior to VE at the 7th day after the treatment (p<0.1), and also at the 14th day in preference comparison (p<0.1). On the other hand, there were no differences between 1% SP and 2% SP at every evaluation day. 2) On the incidence and the symptoms of side effects, no significant differences were observed between 1% SP and VE, or 1% SP and 2% SP. 3) In clinical usefulness 1% SP was significantly superior to VE with respect to preference comparison (p<0.05). But there was no difference between 1% SP and 2% SP. Therefore, it was considered that the clinical suitable concentration of suprofen ointment was 1%. (author abst.) | ||
| Keywords | ||
| Suprofen Ointment, Clinical Suitable Concentration, A Paired Comparative Study, Eczematous Dermatitis | ||
| Serial number | ||
| JRCT87W2227E016 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Evaluation of Clinical Usefulness of Suprofen Ointment in the Treatment of Eczematous Dermatitis and Herpes Zoster: Comparison with Bufexamac Ointment | ||
| Authors | ||
| HARADA Shotaro | ||
| Institutional affiliation of first author | ||
| Kanto Teishin Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(10): 1209-1228 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| The clinical effects of suprofen ointment (SP) were evaluated in 187 patients with eczematous dermatitis and 147 patients with herpes zoster by the comparative studies with bufexamac ointment (BU). 1) There was no significant difference in the global improvement between SP and BU at each evaluation day of each disease. 2) Side effects were observed in 10 out of 272 cases (3.7%) in each drug. Most of the symptoms were observed as the irritation owing to the topical application. 3) The utility rate, more than "useful", was 81.0% and 80.0% in SP and BU respectively on acute eczema and contact dermatitis, and 64.6% and 61.0% in SP and BU respectively on atopic dermatitis. There was no significant difference between SP and BU. On herpes zoster, the utility rate, more than "useful", was 84.6% and 82.2% in SP and BU respectively at the 14th day of the treatment, SP was significantly superior to BU. Therefore, it was considered that the clinical usefulness of suprofen ointment was slightly superior or nearly equal to bufexamac ointment. (author abst.) | ||
| Keywords | ||
| Suprofen Ointment, Comparative Study, Eczematous Dermatitis, Herpes Zoster, Bufexamac Ointment | ||
| Serial number | ||
| JRCT87W2227E017 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Evaluation of Usefulness of Suprofen Ointment in the Treatment of Asteatotic Eczema: Paired Comparative Study with the Vehicle Ointment | ||
| Authors | ||
| HARADA Shotaro | ||
| Institutional affiliation of first author | ||
| Kanto Teishin Hospital | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(10): 1229-1238 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| A paired comparative study on the clinical usefulness of suprofen ointment (SP) for asteatotic eczema carried out with its vehicle ointment (VE) as a reference drug. 1) The data from 77 patients were analyzed. In the inflammatory symptoms of itching and redness on skin findings, SP indicated the significantly superior improvement to VE. 2) In global improvement, SP was significantly superior to VE at the 7th and 14th days after the treatment. Global improvement rate, more than "moderate improvement", was 84.4% and 76.6% in SP and VE respectively. And, in preference comparison of global improvement, SP was significantly superior to VE. The cases, SP was superior, were observed in 30 cases (39.0%), and VE in 14 cases (18.2%). 3) Side effects consisting of itching and redness were observed in 1 case (1.3%) out of 77 cases in SP. 4) The utility rate, more than "Useful", was 76.6% and 66.2% in SP and VE respectively. Moreover, in preference comparison of clinical utility the cases, SP was superior, were observed in 35 cases (45.5%), and VE in 15 cases (19.5%). SP was significantly superior to VE in the utility rate or prefrence comparison. Therefore, it was considered that suprofen ointment was the sufficient useful drug for asteatotic eczema. (author abst.) | ||
| Keywords | ||
| Suprofen Ointment, A Paired Comparative Study, Asteatotic Eczema | ||
| Serial number | ||
| JRCT87W2227E018 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Effects of Cimetidine on Gastric Ulcer Progression to S2 stage: Comparison with Defensive Factor Intensifiers | ||
| Authors | ||
| NISHIGORI Katsuro, TODA Hiroshi, SASAKI Kenji, SUZUKI Ryouichi, SUGIMASA Tatsuo, TAKAMURA Yutaro, HIRABAYASHI Yoshiki, HOSHINO Masato, OKAMURA Atsushi, SATO Shinobu, SATSUTA Masayuki, KATO Takashi, YOSHIMURA Hideki, SHIMADA Makoto | ||
| Institutional affiliation of first author | ||
| Third Department of Internal Medicine, Yokohama City University School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(10): 1269-1282 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| Opinions have long been divided as to which should be considered the proof of gastric ulcer healing, red scar (S1) or white scar (S2). Common practice nowadays is to define the healing stage as clearance of white coating. There is, however, no unified views as to the average time required to reach S2 stage and the difference in recurrence rates between S1 and S2 thereafter. In conducting this study, we adopted the criterion of S2 stage as complete healing. Seventy-three cases of endoscopically-diagnosed gastric ulcer were treated concurrently with cimetidine and a defensive factor intensifier until S1 stage was endoscopically confirmed, followed by assignment either to A Group (cimetidine 800mg day) or to B Group (defensive factor intensifiers) in order to compare the S2 stage progression incidence. Futher, comparative study was made between cases remaining in S1 stage and those that progressed to S2 stage as to some of background factors and recurrence rates. According the life-table method, 12-month cumulative S2 stage progression rate was 42.4% in A group, much higher than 16.1% in B group. As to the cumulative non-recurrence rate during drug therapy, analysis by life-table method showed significant difference between the two groups with 86.8% in A group and 30.0% in B group. (p<0.01). In addition, comparative study of the two groups was made on the patient distribution in three strata at 12 months after treatment: S2-achieved, S1-remaining and recurrence-experienced categroies. Group A was shown to be characterized by significantly high rate of S2 stage progression and low rate of relapse (p<0.01). Site and stage of ulcer were found to be factors influence on achieving S2 stage. The study also indicated the recurrence rate of 14.3% from S2 stage in sharp contrast to the high recurrence rate of 37.5% from S1 stage at 6 months after the therapy was discontinued. These results pinpoint the appropriateness to define S2 stage as the criterion to indicate complete healing of gastric ulcer, and suggests the need to continue treatment vigorously with cimetidine or other H2 blockers even after the disappearance of white coating untill the S2 stage is confirmed. (author abst.) | ||
| Keywords | ||
| S2 Stage Progression Rate, Cimetidine, Defensive Factor Intensifiers | ||
| Serial number | ||
| JRCT87W2227E019 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Phase I Study of Cadralazine (DC-826), an Antihypertensive Drug with Peripheral Vasodilation (2nd Report): Multiple Oral Administration in Healthy Volunteers | ||
| Authors | ||
| NAKASHIMA Mitsuyoshi, UEMATSU Toshihiko, TAKIGUCHI Syorei | ||
| Institutional affiliation of first author | ||
| Department of Pharmacology, Hamamatsu University School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(11): 1319-1342 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| The new antihypertensive drug, Cadralazine, was given orally with multiple administration at a once daily dose of 10mg for 7 days to 6 healthy adult male volunteers on admission to the hospital and the tolerability, pharmacokinetics and pharmacodynamics were studied. At Day 1 and Day 7 the maximum plasma concentration of the unchanged substances was reached at 2 and 1 hour after administration, respectively (118.7ng ml and 158.8ng ml). The biological half-life was approximately 3 hours. The area under the blood concentration vs. time curve (AUC) at Day 1 and Day 7 was 629.4ng ml･hr and 528.4ng ml･hr, respectively. The 24-hour urinary excretion rate from Day 1 to Day 7 was 60.4-71.3% against the dose, causing no marked variation. It is thus considered that Cadralazine has no accumulation even with multiple administration. There was no difference in the urinary excretion of electrolyte (Na+, K+ and Cl-) between Control Day and Day 6, and no accumulation of the electrolyte was noted. After administration of Cadralazine, diastolic blood pressure decreased while pulse rate increased. Subjective symptoms such as hot flushes of face, feeling of hot flushes, nasal obstruction, palpitation and sleepiness were observed. With multiple administration for 7 days in hospitalization, GOT and GPT were being elevated transitionally. Furthermore, the same multiple administration was given for another 14 days to 8 healthy adult male volunteers, two of whom were on placebo. Neither GOT nor GPT was elevated. It was thus considered that the elevated GOT and GPT developed in the 7-day multiple administration have no problem in particular. (author abst.) | ||
| Keywords | ||
| Cardralazine, Healthy Volunteer, Multiple Oral Administration, Tolerability, Accumulation, Pharmacokinetics, Pharmacodynamics | ||
| Serial number | ||
| JRCT87W2227E020 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| A single oral administration study of Cadralazine (DC-826), a peripheral vasodilator, in healthy volunteers: Studies on influence of food, protein binding rate and urinary metabolites | ||
| Authors | ||
| NAKASHIMA Mitsuyoshi, KANAMARU Mitsutaka, HIGASHIO Takahiro, NAKAGAWA Tsutomu, AZUMA Fumihiko, YUHARA Ayami, YOSHIMOTO Tadashi, HAYASHI Hitomi | ||
| Institutional affiliation of first author | ||
| Department of Pharmacology, Hamamatsu University School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(12): 1431-1444 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| Cadralazine, a new antihypertensive drug, was orally administered in ten adult male healthy volunteers at a dose of 10mg with a cross-over design given during fasting and 30 minutes after meals and the influence of food was studied. The area under the plasma concentration vs. time curve (AUC(0-24)), the maximum plasma concentration (Cmax), the time to reach the maximum plasma concentration (Tmax), the half-life (T 1 2) and the cumulative urinary excretion amount were compared by the analysis of variance. The results were that no significant differences were observed between the values during fasting and those after meals and the influence of food was considered to be little. Three kinds of urinary metabolites were determined and the amount of each metabolite against the dosage was very small: 3.4% for M-I, 0.4% for M-II and 0.8% for M-III. The protein binding rate in the plasma was approximately 13.6%. (author abst.) | ||
| Keywords | ||
| Cadralazine, Healthy Volunteer, Influence of Food, Protein Binding Rate, Urinary Metabolite | ||
| Serial number | ||
| JRCT87W2227E021 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Study of CS-514 on Hyperlipidemia: Dose Finding Study using Double-blind, Three-Groups Comparative Study | ||
| Authors | ||
| SAITO Yasushi, YOSHIDA Sho, SHIRAI Koji, SASAKI Norihiro, SHINOMIYA Masaki, MURANO Syunichi, MORISAKI Nobuhiro, NISHIIDE Toshio, KANZAKI Tetsuto, WATANABE Naoko, GOTO Yuichiro, NAKAYA Noriaki, HOMMA Yasuhiko, HATA Yoshiya, YAMAMOTO Minoru, NAITO Chikayuki, HAYASHI Hirosh | ||
| Institutional affiliation of first author | ||
| Second Department of Medicine, Chiba University School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(12): 1445-1472 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| To determine a clinically optimal dosage of CS-514 as a cholesterol lowering agent, doubleblind study was performed by administering 0, 10 and 20 mg day of CS-514 to 118 hyperlipidemic patients. 1) Comparing to initial values of serum total cholesterol, those values after 8 weeks of administration were +2.9%, -16.1% and -20.5% in the placebo, 10mg and 20mg groups, respectively. Dose dependency was observed between the 10mg and 20mg groups. 2) Triglyceride levels did not changed significantly in all groups. 3) HDL-cholesterol levels after 8 weeks of administration increased significantly by +13.4% and +7.8% in 10mg and 20mg group respectively, while +4.5% in placebe group. Dose dependency was not observed. 4) LDL-cholesterol levels at 8 weeks of administration were +4.8%, -23.9% (p<0.01) and -29.8% (p<0.001) in the placebo, 10mg and 20mg groups, comparing to initial those values. 5) Apolipoprotein B levels decreased in the 10mg and 20mg groups, but dose dependency was not observed. Apolipoprotein A-I increased in 10mg and 20mg groups. Apolipoprotein A-II, C-II, C-III and E were not affected in all three groups. 6) Atherogenic index in the 10mg and 20mg groups were improved at 8 weeks of administration. But dose dependency was not observed. 7) No remarkable side effects of CS-514 administration were reported. 8) No abnormal laboratory findings were noted. 9) Judgement of utility of CS-514 by doctors was devided into three groups. Among them, "very useful" plus "useful" subjects were 13.0%, 87.8% and 90.9% respectively in the placebo, 10mg and 20mg groups. But the significant difference between the 10mg and 20mg groups was not observed. From these results, a clinically optimal dosage of CS-514 was considered to be 10mg a day. (author abst.) | ||
| Keywords | ||
| CS-514, HMG-CoA Reductase Inhibitor, Hyperlipidemia, Dose Finding Study | ||
| Serial number | ||
| JRCT87W2227E022 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Assessment of Clinical Advantages Derived from β1 Selectivity of Atenolol | ||
| Authors | ||
| EBIHARA Akio, FUJIMURA Akio, HINO Naoko, SUGIMOTO Koichi, KUMAGAI Yuji, NAKASHIMA Hajime, KAWASHIMA Koichiro | ||
| Institutional affiliation of first author | ||
| Department of Clinical Pharmacology and Therapeutics, Oita Medical University | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(12): 1473-1483 | ||
| Research Design | ||
| RCT | ||
| Abstract | ||
| Six healthy volunteers were randomly administered either atenolol or timolol on a double-blind cross-over design in elucidating clinical significance of beta 1 selectivity. Atenolol was dosed 50mg u.i.d. (AM) along with the matching placebo b.i.d. (noon and PM) for 7 days whereas timolol 5mg was given t.i.d. 14 days washout period was provided between the two dosing periods. Temperature and blood flow at finger tips were measured prior to and at the end of 7 day dosing period. Exercise tests with fixed loading were conducted in an attempt to evaluate effect of each drug on plasma lactic acid and muscle fatigue. There was no difference elicited on finger tip temperature at the end of each dosing period from the base line temperature. Timolol reduced finger tip blood flow when measured preceding the exercise test whereas atenolol failed to reduce. However the exercise loading attenuated the blood flow significantly when compared to the pre-exercise recordings in cases of the both drugs. But timolol suppressed the blood flow more than atenolol with statistical significance. Among those who attained increases in plasma lactic acid levels 5 out of 6 yielded less increases on atenolol than on timolol but the remaining one showed slightly more elevation on atenolol. Moreover, the former 5 volunteers claimed to have experienced less muscle fatigue on atenolol during the exercise tests than on timolol. In considerations of the aforementioned, beta 1 selective beta blockers exert less impact on blood flow and give rise to muscle fatigue less markedly. Consequently, beta 1 selective agents may be more advantageous than non-selective beta blockers even when uncomplicated with bronchial asthma and Raynaud's disease. (author abst.) | ||
| Keywords | ||
| Beta 1 Selective Beta Blocker, Atenolol, Finger-Tip Blood Flow, Muscular Fatigue | ||
| Serial number | ||
| JRCT87W2227E023 | ||
| Handsearcher | ||
| Nemoto | ||
|
| ||
| Title | ||
| Clinical Trial of Niceritrol (Perycit) on Vibration Syndrome | ||
| Authors | ||
| AGISHI Yuko, IWAKAWA Yukimasa, SHIRAKAWA Hisanari, NISHIHARA Hisashi, SAKAI Hiroshi | ||
| Institutional affiliation of first author | ||
| Noboribetsu Branch Hospital, Hokkaido University School of Medicine | ||
| Source | ||
| Rinsho Iyaku (Journal of Clinical Therapeutics and Medicines) 1987; 3(11): 1395-1407 | ||
| Research Design | ||
| CCT | ||
| Abstract | ||
| The effects of niceritrol (Perycit) on the peripheral circulatory, nerval, and motor disturbances in 96 patients with vibration syndrome were studied. After 4 weeks administration of niceritrol (in 47 cases 750mg day and in 49 cases 1,500mg day), these disturbances, especially circulatory disturbance, were improved markedly; in function tests, the recovery rate of skin temperature in cold provocation test showed significant improvement with reduction of subjective symptoms. Moreover, vibration sense threshold and motor functions showed significant improvement. These effects were observed greater in 1,500mg day administered group than in 750mg day administered group. These results suggest that niceritrol is an useful drug in treatment of peripheral circulatory disturbance of vibration syndrome. (author abst.) | ||
| Keywords | ||
| Vibration Syndrome, Drug Therapy, Niceritrol (Perycit), Dose Response, Circulatory Function | ||
| Serial number | ||
| JRCT87W2227E027 | ||
| Handsearcher | ||
| Nemoto | ||