NCT00542789

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

A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of Esomeprazole(20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Gastric Ulcer
• Duodenal Ulcer
• Rheumatoid Arthritis
• Osteoarthritis
• Lumbago

Interventions

Type	Name	Description
DRUG	Esomeprazole	20mg once daily oral
DRUG	Placebo	once daily oral

Timeline

• Start date: 2007-08-01
• Completion: 2009-02-01
• First posted: 2007-10-12
• Last updated: 2010-05-28
• Results posted: 2010-05-28

Locations

39 sites across 1 country: Japan