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

NCT00641004 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2011-08-24

No results posted yet for this study

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

DRUG

Rebamipide and Esomeprazole

1. Rebamipide 100mg TID for 12 weeks 2. Esomeprazole 40mg OD + Esomeprazole-matching placebo BID for 12 weeks

Sponsors & Collaborators

  • Otsuka Pharmaceutical, Inc., Philippines

    lead INDUSTRY

Principal Investigators

  • Jose Sollano, MD · University of Santo Tomas Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00641004 on ClinicalTrials.gov