Korean J Gastrointest Endosc > Volume 31(1); 2005 > Article
Korean Journal of Gastrointestinal Endoscopy 2005;31(1): 17-24.
십이지장궤양에 대한 레바프라잔 정제의 제3상 임상시험
정인식*·최명규*·박수헌*·김성국†·장 린‡·현진해§·한상영∥·송근암¶·심찬섭**·함기백††·김현수‡‡·김태년§§·최석채∥∥·설상영¶¶·유종선***·김동준†††·이 진†††·최호순‡‡‡·송근석§§§·문병석§§§·주상언§§§
가톨릭대학교 의과대학 소화기내과학교실*, 경북대학교 의과대학 소화기내과학교실†, 경희대학교 의과대학 소화기내과학교실‡, 고려대학교 의과대학 소화기내과학교실§, 동아대학교 의과대학 소화기내과학교실∥, 부산대학교 의과대학 소화기내과학교실¶, 순천향대학교 의과대학 소화기내과학교실**, 아주대학교 의과대학 소화기내과학교실††, 연세대학교 원주의과대학 소화기내과학교실‡‡, 영남대학교 의과대학 소화기내과학교실§§, 원광대학교 의과대학 소화기내과학교실∥∥, 인제대학교 의과대학 소화기내과학교실¶¶, 전남대학교 의과대학 소화기내과학교실***, 한림대학교 의과대학 소화기내과학교실†††, 한양대학교병원 소화기내과학교실‡‡‡, 유한양행§§§
Revaprazan (RevanexⰒ), a Novel Acid Pump Antagonist, for Duodenal Ulcer: Results of a Double-Blind, Randomized, Parallel, Multi-Center Phase III Clinical Trial
In-Sik Chung, M.D.*, Myung-Gyu Choi, M.D.*, Soo-Heon Park, M.D.*, Sung-Kook Kim, M.D.†, Rhyn Chang, M.D.‡,

Jin-Hai Hyun, M.D.§, Sang-Young Han, M.D.∥, Geun-Am Song, M.D.¶, Chan-Sup Shim, M.D.**, Ki-Baik Hahm, M.D.††, Hyun-Soo Kim, M.D.‡‡,

*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, §Korea University College of Medicine, Seoul, ∥Dong-A University College of Medicine, Busan, ¶Pusan National University College of Medicine, Busan, **Soonchunhyang University College of Medicine, Seoul, ††Ajou University College of Medicine, Suwon, ‡‡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:
To assess the comparative efficacy and safety of revaprazan, a novel acid pump antagonist, versus omeprazole in patients with duodenal ulcer, we performed a randomized, double-blind, phase III, multicenter trial.
Methods:
Two hundred and twenty eight patients were randomized to 4 weeks of treatment with either revaprazan 200 mg or omeprazole 20 mg once daily. Primary efficacy parameter was complete ulcer healing by endoscopy, and secondary parameter was the improvement in the severity of daytime and nighttime pain.
Results:
Healing rates at 4 weeks (intention-to-treat analysis) were 91.7% with revaprazan 200 mg and 91.3% with omeprazole 20 mg; there were no significant differences between two groups (p=0.9228). In per-protocol analysis, healing rates of revaprazan 200 mg and omeprazole 20 mg were 94.4% and 92.3%, respectively. There was no significant difference in healing rate between two groups (p=0.5666). There was no significant difference between two groups in improvement rates of daytime and nighttime pain. Both drugs were well tolerated.
Conclusions:
Revaprazan 200 mg was equivalent to omeprazole 20 mg for both ulcer healing and symptom relief, and was well tolerated in patients with duodenal ulcer. (Korean J Gastrointest Endosc 2005;31:17⁣24)
Key Words: Revaprazan, Omeprazole, Duodenal ulcer, Phase III clinical trial
주요어: 레바프라잔, 오메프라졸, 십이지장궤양, 3상 임상시험
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