NCT00441727

Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)

A Randomized, Double-blind, Parallel-group, Multicentre, Phase III Study to Assess the Effect of Esomeprazole 20 or 40 mg od Versus Placebo on the Occurrence of Peptic Ulcers During 26 Weeks in Subjects on Continuous Low Dose Acetylsalicylic Acid (ASA)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,426 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.

Conditions

• Gastric Ulcer
• Duodenal Ulcer

Interventions

Type	Name	Description
DRUG	Esomeprazole 40 mg	Esomeprazole 40 mg once daily
DRUG	Esomeprazole 20 mg	Esomeprazole 20 mg once daily
DRUG	Placebo	Placebo once daily

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-08-01
• Completion: 2008-08-01
• First posted: 2007-03-01
• Last updated: 2012-07-16
• Results posted: 2012-02-13

Locations

189 sites across 20 countries: United States, Argentina, Australia, Bulgaria, Canada, Czechia, Finland, Germany, Indonesia, Mexico, Norway, Philippines, Poland, Portugal, Romania, Russia, Slovakia, South Africa, South Korea, Thailand