Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- To assess the efficacy of esomeprazole versus placebo through 6 months of treatment for the prevention of relapse of upper GI symptom associated with NSAID use
- To assess the safety & tolerability of esomeprazole versus placebo when administered for 6 months to patients receiving daily NSAID therapy.
|Study Start Date:||April 2001|
|Study Completion Date:||February 2003|
|Primary Completion Date:||February 2003 (Final data collection date for primary outcome measure)|
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|Study Director:||AstraZeneca Nexium Medical Sciences Director, MD||AstraZeneca|