NCT00241553

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

Efficacy of Esomeprazole 40 mg Once Daily Versus Placebo or Esomeprazole 20 mg Once Daily Versus Placebo in Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 276 (planned)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 theefficacy 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.

Conditions

• NSAIDs
• Upper GI Symptoms

Interventions

Type	Name	Description
DRUG	Esomeprazole

Timeline

• Start date: 2001-04-01
• Primary completion: 2003-02-01
• Completion: 2003-02-01
• First posted: 2005-10-19
• Last updated: 2011-01-24

Locations

136 sites across 11 countries: United States, Australia, Canada, Czechia, Italy, Norway, Poland, Slovakia, South Africa, Sweden, United Kingdom