NCT00576706

PReventive Efficacy and Safety of rEbamipide on Nsaid Induced Mucosal Toxicity

A Phase III, Randomized, Double-dummy, Double Blind, Misoprostol-comparative Clinical Trial to Evaluate the Efficacy and Safety of Mucosta® Tablet in the Prevention of NSAID-induced Gastrointestinal Complications

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 396 (estimated)
• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis
• Osteoarthritis
• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Rebamipide	Rebamipide 100㎎, 12 weeks
DRUG	Misoprostol	Misoprostol 200㎍ 12 weeks

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2007-12-19
• Last updated: 2011-11-16

Locations

10 sites across 1 country: South Korea