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) 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
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