drugset / Trial / NCT00542789

Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID

NCT00542789

Phase 3 Completed 343 enrolled AstraZeneca
RandomizedParallel-groupQuadruple-blindPrevention

Summary

The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers

Timeline

Start
2007-08
Primary completion
Completion
2009-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Esomeprazole Small molecule 20 mg Oral