Clinical Evaluation of Pariet 10mg Tablets in Patients with Gastric Ulcer Diseases.

Accession number;02A0852164
Title;Clinical Evaluation of Pariet 10mg Tablets in Patients with Gastric Ulcer Diseases.
Author;SAIGENJI KATSUNORI(Kitasato Univ., East Hosp.)   YOKOTA KIN'ICHI(Asahikawa Med. Coll., Sch. of Med.)   KURE TEIKICHI(Asahikawa Red Cross Hospital, JPN)   KONNO JUN(Hakodate Koseiin Hakodate Central Hosp.)   MOCHIZUKI FUKUJI(East Japan Railway Co., JR Sendai Hospital, JPN)   MITAJI TAIJI(Koseikai Sendai Kosei Hospital, JPN)   EDA KOKI(Sendai Municipal Hospital, JPN)   KOMATSU MASAFUMI(Akita Municipal Hospital, JPN)   MAEDA KAZUHIRO(Kumamoto National Hospital, JPN)   
Journal Title;Japanese Pharmacology & Therapeutics
Journal Code:Z0947A
ISSN:0386-3603
VOL.30;NO.9;PAGE.675-693(2002)
Figure&Table&Reference;FIG.8, TBL.11, REF.26
Pub. Country;Japan
Language;Japanese
Abstract;In a multicenter, randomaized, non-blinded, parallel group comparison study, the transition rate to S2-stage was studied after eight weeks administration of rabeprazole (Pariet 10mg Tablet) (PAR group) and H2-blocker (H2A group). The study included 193 patients with endoscopically diagnosed active-atage (A1, A2) gastric ulcer. Efficacy analysis included 153 patients (PAR group; 77 cases, H2A group; 76 cases) eligible for endoscopic findings and 170 patients (PAR group; 85 cases, H2A group; 85 cases) eligible for subjective symptoms. Safety analysis included 187 patients (PAR group; 92 cases, H2A group; 95 cases) eligible for adverse evevts and 168 patients (PAR group; 81 cases, H2A group; 87 cases) eligible for laboratory test results. Favorable rates of healing in gastric ulcer after four and eight weeks of administration were observed in both the treatment groups; namely, 60.0% (45/75 cases) and 93.5% (72/77 cases) respectively in the PAR group and 43.4% (33/76 cases) and 85.5% (65/76 cases) respectively in the H2A group. After four weeks of treatment, the transition retes to S2-stage, where ulcer with scar is observed, 12.0% (9/75) in the PAR group and 6.6% (5/76 cases) in the H2A group. The final transition rates to the S2-stage, the primary efficacy endpoint, were 40.3% (34/77 cases) in the PAR group and 27.6% (21/76 cases) in the H2A group. Although the final rate was higher in the PAR group, no significant difference was observed (p=0.125). Stratified by the background of the patients, transition rates to the S2-stage after four weeks of treatment of were 15.6% (5/32 cases) and 40.0% (4/10 cases) for the PAR patients who were at the A1-stage of ulcer or had multiple ulcer respectively. The PAR group showed a transition retes significantly higher than the H2A group (p=0.018 and p=0.024, respectively).... (author abst.)