Phase III Clinical Trial of Revaprazan (Revanex<SUP>Ⱂ</SUP>) for Gastric Ulcer

Korean J Gastrointest Endosc > Volume 34(6); 2007 > Article

Korean Journal of Gastrointestinal Endoscopy 2007;34(6): 312-319.

위궤양에 대한 레바프라잔 정제의 제3상 임상시험

장 린*·정인식^†·박수헌^†·김성국^‡·최석렬^§·송근암^∥·함기백^¶·이용찬**·김현수^††· 김태년^‡‡·최석채^§§·설상영^∥∥·유종선^¶¶·김동준***·이 진***·최호순^†††·이정은^‡‡‡·송근석^‡‡‡·문병석^‡‡‡·주상언^‡‡‡

*경희대학교 의과대학, ^†가톨릭대학교 의과대학, ^‡경북대학교 의과대학, ^§동아대학교 의과대학, ^∥부산대학교 의과대학, ^¶아주대학교 의과대학, **연세대학교 의과대학, ^††연세대학교 원주의과대학, ^‡‡영남대학교 의과대학, ^§§원광대학교 의과대학, ^∥∥인제대학교 의과대학, ^¶¶전남대학교 의과대학, ***한림대학교 의과대학, ^†††한양대학교 의과대학 소화기내과학교실, ^‡‡‡(주)유한양행

Phase III Clinical Trial of Revaprazan (Revanex^Ⱂ) for Gastric Ulcer

Rin Chang, M.D.*, In Sik Chung, M.D.^†, Soo-Heon Park, M.D.^†, Sung-Kook Kim, M.D.^‡, Seok-Reyol Choi, M.D.^§, Geun-Am Song, M.D.^∥, Ki-Baik Hahm, M.D.^¶, Yong-Chan Lee, M.D.**, Hyun-Soo Kim, M.D

Department of Gastroenterology, *Kyunghee University College of Medicine, Seoul, ^†The Catholic University of Korea College of Medicine, Seoul, ^‡Kyungpook National University College of Medicine, Daegu, ^§Dong-A University College of Medicine, Busan, ^∥Pusan National University College of Medicine, Busan, ^¶Ajou University College of Medicine, Suwon, **Yonsei University College of Medicine, Seoul, ^††Yonsei University Wonju College of Medicine, Wonju, ^‡‡YeungNam University College of Medicine, Daegu, ^§§Wonkwang University College of Medicine, Iksan, ^∥∥Inje University College of Medicine, Busan, ^¶¶Chonnam National University College of Medicine, Gwangju, ***Hallym University College of Medicine, Chuncheon, ^†††Hanyang University College of Medicine, Seoul, ^‡‡‡Yuhan Corporation, Seoul, Korea

Abstract

Background/Aims:
This randomized, double-blind, phase III, multicenter trial was carried out to compare the efficacy and safety of revaprazan, a novel acid pump antagonist, with that of omeprazole in patients with more than one of gastric ulcers.
Methods:
Two hundred and ninety two subjects were randomized to 4∼8 weeks of treatment with either revaprazan 200 mg or omeprazole 20 mg. The primary efficacy parameter was the cumulative healing rate determined by endoscopy after 4 and 8 weeks of treatment, and the secondary efficacy parameter was an improvement rate of pain.
Results:
The intention-to-treat analysis revealed revaprazan and omeprazole to have similar cumulative healing rates (93.0% and 89.6%, respectively; p=0.3038). The per-protocol analysis revealed revaprazan and omeprazole to also have similar cumulative healing rates (99.1% and 100%, respectively; p= 0.3229). In both analyses, there were no significant differences in an improvement rate of pain between the two groups. Both drugs were well tolerated.
Conclusions:
Revaprazan has similar efficacy to omeprazole in the treatment of patients with gastric ulcer with a once a day application of revaprazan 200 mg or omeprazole 20 mg over a 4 to 8-week period. In terms of safety, revaprazan was well tolerated.

Key Words: Revaprazan, Omeprazole, Gastric ulcer, Clinical trial phase III

주요어: 레바프라잔, 오메프라졸, 위궤양, 3상시험