drugset / Trial / NCT00241514

Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs

NCT00241514

Phase 3 Completed 334 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

Summary

This study was a multicentre, double-blind, randomised, placebo-controlled parallel group study consisting of 4 visits over a period of 6 months. The primary variable was to assess the efficacy of esomeprazole 40 mg orally qd (E40) or esomeprazole 20 mg orally qd (E20) versus placebo orally qd after 6 months of treatment for the prevention of relapse of upper GI symptoms associated with NSAID use, including COX-2 selective NSAIDs, in patients receiving daily NSAID therapy.

Timeline

Start
2001-02
Primary completion
2003-02
Completion
2003-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Esomeprazole Small molecule 20 mg Oral
Subject Esomeprazole Small molecule 40 mg Oral