Korean J Gastrointest Endosc.  2007 Jun;34(6):312-319.

Phase III Clinical Trial of Revaprazan (Revanex(R)) for Gastric Ulcer

Affiliations
  • 1Department of Gastroenterology, Kyunghee University College of Medicine, Seoul, Korea. kmcim@chollian.net
  • 2Department of Gastroenterology, The Catholic University of Korea College of Medicine, Seoul, Korea.
  • 3Department of Gastroenterology, Kyungpook National University College of Medicine, Daegu, Korea.
  • 4Department of Gastroenterology, Dong-A University College of Medicine, Busan, Korea.
  • 5Department of Gastroenterology, Pusan National University College of Medicine, Busan, Korea.
  • 6Department of Gastroenterology, Ajou University College of Medicine, Suwon, Korea.
  • 7Department of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.
  • 8Department of Gastroenterology, Yonsei University Wonju College of Medicine, Wonju, Korea.
  • 9Department of Gastroenterology, YeungNam University College of Medicine, Daegu, Korea.
  • 10Department of Gastroenterology, Wonkwang University College of Medicine, Iksan, Korea.
  • 11Department of Gastroenterology, Inje University College of Medicine, Busan, Korea.
  • 12Department of Gastroenterology, Chonnam National University College of Medicine, Gwangju, Korea.
  • 13Department of Gastroenterology, Hallym University College of Medicine, Chuncheon, Korea.
  • 14Department of Gastroenterology, Hanyang University College of Medicine, Seoul, Korea.
  • 15Yuhan 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.

Keyword

Revaprazan; Omeprazole; Gastric ulcer; Clinical trial phase III
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