At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,426 enrolled
Drug / intervention
Esomeprazole 40 mg +2 moredrug
Likely dose
Esomeprazole 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Esomeprazole 40 mg, Esomeprazole 20 mg, and 1 other intervention for Gastric Ulcer and Duodenal Ulcer. Completed, enrolled 2,426 participants across 189 sites in 20 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Ulcer, Duodenal Ulcer
CountriesArgentina, Australia, Bulgaria, Canada, Czechia, Finland, Germany, Indonesia, Mexico, Norway, Philippines, Poland, Portugal, Romania, Russia, Slovakia, South Africa, South Korea, Thailand, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2007
First PostedMar 2007
Primary CompletionAug 2008
TodayJul 2026
First PostedMar 1, 2007
Enrollment StartFeb 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.3 years ago
Interventions
Esomeprazole 40 mgdrug
Esomeprazole 40 mg once daily
Esomeprazole 20 mgdrug
Esomeprazole 20 mg once daily
Placebodrug
Placebo once daily