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- Phase III Clinical Trial of Revaprazan (RevanexⰒ) for Gastric Ulcer
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Clinical Endoscopy 2007;34(6):312-319.
DOI: https://doi.org/
Published online: June 30, 2007
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
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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.
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