At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 519 enrolled
Drug / intervention
PA32540 +1 moredrug
Likely dose
EC-Aspirin 325 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 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PA32540 or Enteric Coated Aspirin 325 mg in Subjects Who Are at Risk for Developing Aspirin-Associated Ulcers
In Brief
A Phase 3 clinical trial evaluating PA32540 and EC-Aspirin 325 mg for Gastric Ulcer. Completed, enrolled 519 participants across 1 site.
Detailed Summary
Primary: To demonstrate that PA32540 causes fewer gastric ulcers in subjects at risk for developing aspirin-associated gastric ulcers compared to enteric coated (EC) aspirin 325 mg.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric Ulcer
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2009
Enrollment StartOct 2009
Primary CompletionFeb 2012
TodayJul 2026
First PostedAug 18, 2009
Enrollment StartOct 1, 2009
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.9 years ago
Interventions
PA32540drug
PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole
EC-Aspirin 325 mgdrug
The comparator aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole)