drugset / Trial / NCT00641004

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

NCT00641004

Phase 4 Completed 30 enrolled Otsuka Pharmaceutical Co., Ltd.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2008-04
Primary completion
2010-03
Completion
2010-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Esomeprazole Small molecule 40 mg
Subject Rebamipide Small molecule 100 mg

Indications