Trial intelligence / Profile preview

Rebamipide vs Esomeprazole in NSAID-induced Gastropathy

NCT00641004Phase 4

Key facts

Status: Completed
Start: Apr 2008
Primary completion: Mar 2010
Countries: 1
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Modality: Small Molecules

Drugs: rebamipide
Conditions: NSAID-induced gastropathy

Overview

Phase 4, randomised, double-blind trial of rebamipide in NSAID-induced gastropathy (2 arms), sponsored by Otsuka Pharmaceutical Co., Ltd. Primary endpoints: Malondialdehyde levels and Immunohistochemistry surrogate of inflammation. Started Apr 2008; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Rebamipide
Rebamipide 100mg TID
Esomeprazole
Esomeprazole 40mg OD + Placebo

Who it enrols

Adult patients (18-65) with RA or OA on NSAIDs for >4 weeks with dyspeptic symptoms and gastric mucosal lesions (Lanza score >= 1), excluding those with H. pylori, malignancy, or severe comorbidities.

Endpoints

Primary

Malondialdehyde levelsThroughout the study
Immunohistochemistry surrogate of inflammationThroughout the study

Secondary

Proportion of patients with positive treatment effects using the Likert scaleThroughout the study

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