PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity

Phase 3 Completed 396 enrolled Korea Otsuka Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindPrevention

Summary

To prove that the efficacy and safety of Mucosta® (Rebamipide) is non-inferior to those of Cytotec® (Misoprostol), in terms of prevention of NSAID-induced gastric ulcer.

Timeline

Start: 2007-12
Primary completion: 2010-03
Completion: 2010-03

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Misoprostol	Other / unclassified	200 ug	—
Subject	Rebamipide	Small molecule	100 mg	—

PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity

Summary

Timeline

Drugs

Indications