Phase III Clinical Trial of Revaprazan (Revanex<SUP>Ⓡ</SUP>) for Gastritis

Korean J Gastrointest Endosc > Volume 33(4); 2006 > Article

Korean Journal of Gastrointestinal Endoscopy 2006;33(4): 212-219.

위염에 대한 레바프라잔 정제의 제3상 임상시험

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

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

Phase III Clinical Trial of Revaprazan (Revanex^Ⓡ) for Gastritis

Myung-Gyu Choi, M.D., Soo-Heon Park, M.D., Sung-Kook Kim, M.D.*, Rin Chang, 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.**, Tae-Nye

Department of Gastroenterology, The Catholic University of Korea College of Medicine, Seoul, *Kyungpook National University College of Medicine, Daegu, ^†Kyunghee University College of Medicine, Seoul, ^‡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:
We performed a randomized, double-blind, phase III, multicenter trial to assess the comparative efficacy and safety of revaprazan, which is a novel acid pump antagonist in comparison with ranitidine for treating patients suffering with acute gastritis and acute aggravation of chronic gastritis.
Methods:
Five hundred and twelve subjects were randomized to 2 weeks of treatment with either revaprazan 200 mg q.d. or ranitidine 150 mg b.i.d. The primary efficacy parameter was the estimated improvement rate according to endoscopy, and the secondary efficacy parameter was the improvement rate for the subjects' symptoms.
Results:
The estimated improvement rates at 2 weeks (intention-to-treat analysis) were 79.9% with revaprazan and 60.5% with ranitidine; a significant difference was found between the two groups (p＜0.0001). On the per-protocol analysis, the estimated improvement rates for revaprazan and ranitidine were 79.4% and 60.2%, respectively. There was a significant difference in the estimated improvement rates between the two groups (p＜0.0001). On both analyses, there were no significant differences between the two groups for the improvement rates of the subjects' symptoms. Both drugs were well tolerated.
Conclusions:
The efficacy of revaprazan was higher than that of ranitidine for the estimated improvement rate according to endoscopy and also for the symptomatological improvement rate, and revaprazan was well tolerated by the subjects suffering with gastritis. (Korean J Gastrointest Endosc 2006;33:212⁣219)

Key Words: Revaprazan, Ranitidine, Gastritis, Clinical Trial

주요어: 레바프라잔, 라니티딘, 위염, 3상시험