Korean J Gastrointest Endosc.  2005 Jul;31(1):17-24.

Revaprazan (Revanex(R)), a Novel Acid Pump Antagonist, for Duodenal Ulcer: Results of a Double-Blind, Randomized, Parallel, Multi-Center Phase III Clinical Trial

Affiliations
  • 1Department of Gastroenterology, The Catholic University of Korea College of Medicine, Seoul, Korea. isc@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, Korea University College of Medicine, Seoul, Korea.
  • 5Department of Gastroenterology, Dong-A University College of Medicine, Busan, Korea.
  • 6Department of Gastroenterology, Pusan National University College of Medicine, Busan, Korea.
  • 7Department of Gastroenterology, Soonchunhyang University College of Medicine, Seoul, Korea.
  • 8Department of Gastroenterology, Ajou University College of Medicine, Suwon, Korea.
  • 9Department of Gastroenterology, Yonsei University Wonju College of Medicine, Wonju, Korea.
  • 10Department of Gastroenterology, Yeungnam University College of Medicine, Daegu, Korea.
  • 11Department of Gastroenterology, Wonkwang University College of Medicine, Iksan, Korea.
  • 12Department of Gastroenterology, Inje University College of Medicine, Busan, Korea.
  • 13Department of Gastroenterology, Chonnam National University College of Medicine, Gwangju, Korea.
  • 14Department of Gastroenterology, Hallym University College of Medicine, Chuncheon, Korea.
  • 15Department of Gastroenterology, Hanyang University College of Medicine, Seoul, Korea.
  • 16Yuhan Corporation, Seoul, Korea.

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.

Keyword

Revaprazan; Omeprazole; Duodenal ulcer; Phase III clinical trial
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