At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 427 enrolled
Drug / intervention
Esomeprazole +1 moredrug
Likely dose
Esomeprazole 20mgfrom 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 Phase III Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for Prevention of Gastric and/or Duodenal Ulcers Associated With Continuous Low-dose Aspirin (LDA) Use
In Brief
A Phase 3 clinical trial evaluating Esomeprazole and Placebo for Prevention. Completed, enrolled 427 participants across 46 sites in 3 countries.
Detailed Summary
To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric and/or duodenal ulcers.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrevention
CountriesJapan, South Korea, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2010
First PostedFeb 2010
Primary CompletionNov 2011
TodayJul 2026
First PostedFeb 17, 2010
Enrollment StartFeb 1, 2010
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.4 years ago
Interventions
Esomeprazoledrug
20mg, capsule, 72 weeks
Placebodrug
Placebo, capsule, 72 weeks