drugset / Trial / NCT00633412

A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued in Subjects in the US Only

NCT00633412

Phase 3 Completed 400 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

Summary

Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the treatment of these gastric ulcers with one of the three following treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily for subjects in the US only.

Timeline

Start
2001-02
Primary completion
Completion
2003-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Esomeprazole Small molecule 20 mg Oral
Subject Esomeprazole Small molecule 40 mg Oral
Comparator Ranitidine Unknown 150 mg Oral