NCT00641004

Randomized Double-Blind Clinical Trial of Rebamipide vs Esomeprazole in the Treatment of NSAID-induced Gastropathy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Otsuka Pharmaceutical, Inc., Philippines · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Primary objective: To determine the levels of malondialdehyde (MDA) and immunohistochemistry surrogate of inflammation in patients with NSAID-induced gastric mucosal injury treated with Rebamipide 3x a day vs Esomeprazole 40mg once a day. Secondary objective: For patients who become symptomatic during NSAID treatment, to compare the proportion of patients with positive treatment effects using the Likert scale. Third objective: To compare the proportion of patients with positive treatment effects as determined by Modified Lanza scoring between the two groups.

Conditions

• NSAID Induced Gastropathy

Interventions

Type	Name	Description
DRUG	Rebamipide and Esomeprazole	1. Rebamipide 100mg TID for 12 weeks 2. Esomeprazole 40mg OD + Esomeprazole-matching placebo BID for 12 weeks

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-03-01
• Completion: 2010-03-01
• First posted: 2008-03-21
• Last updated: 2011-08-24

Locations

4 sites across 1 country: Philippines