KSGE
Articles
- Page Path
- HOME > Clin Endosc > Volume 31(1); 2005 > Article
- Revaprazan (RevanexⰒ), a Novel Acid Pump Antagonist, for Duodenal Ulcer: Results of a Double-Blind, Randomized, Parallel, Multi-Center Phase III Clinical Trial
-
Clinical Endoscopy 2005;31(1):17-24.
DOI: https://doi.org/
Published online: July 30, 2005
*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
- 2,476 Views
- 43 Download
- 0 Crossref
- 0 Scopus
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;31:1724)
Cite
