Trials / Completed
CompletedNCT00241514
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
- 334 (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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Esomeprazole |
Timeline
- Start date
- 2001-02-01
- Primary completion
- 2003-02-01
- Completion
- 2003-02-01
- First posted
- 2005-10-19
- Last updated
- 2011-01-21
Locations
113 sites across 6 countries: United States, Belgium, France, Germany, Hungary, Spain
Source: ClinicalTrials.gov record NCT00241514. Inclusion in this directory is not an endorsement.