Korean J Gastrointest Endosc.  2006 Oct;33(4):212-219.

Phase III Clinical Trial of Revaprazan (Revanex(R)) for Gastritis

Affiliations
  • 1Department of Gastroenterology, The Catholic University of Korea College of Medicine, Seoul, Korea. choim@catholic.ac.kr
  • 2Department of Gastroenterology, Kyungpook National University College of Medicine, Daegu, Korea.
  • 3Department of Gastroenterology, Kyunghee University College of Medicine, Seoul, 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: We performed a randomized, double-blind, phase III, multicenter trial to assess the comparative efficacy and safety of revaprazan, which is a novel acid pump antagonist in comparison with ranitidine for treating patients suffering with acute gastritis and acute aggravation of chronic gastritis.
METHODS
Five hundred and twelve subjects were randomized to 2 weeks of treatment with either revaprazan 200 mg q.d. or ranitidine 150 mg b.i.d. The primary efficacy parameter was the estimated improvement rate according to endoscopy, and the secondary efficacy parameter was the improvement rate for the subjects' symptoms.
RESULTS
The estimated improvement rates at 2 weeks (intention-to-treat analysis) were 79.9% with revaprazan and 60.5% with ranitidine; a significant difference was found between the two groups (p<0.0001). On the per-protocol analysis, the estimated improvement rates for revaprazan and ranitidine were 79.4% and 60.2%, respectively. There was a significant difference in the estimated improvement rates between the two groups (p<0.0001). On both analyses, there were no significant differences between the two groups for the improvement rates of the subjects' symptoms. Both drugs were well tolerated.
CONCLUSIONS
The efficacy of revaprazan was higher than that of ranitidine for the estimated improvement rate according to endoscopy and also for the symptomatological improvement rate, and revaprazan was well tolerated by the subjects suffering with gastritis.

Keyword

Revaprazan; Ranitidine; Gastritis; Clinical Trial
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