At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 380 enrolled
Drug / intervention
PA32540drug
Likely dose
PA32540 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 12-Month, Phase 3, Open-Label, Multi-Center Study to Evaluate the Long-Term Safety of PA32540 in Subjects Who Are at Risk for Developing Aspirin-Associated Gastric Ulcers
In Brief
A Phase 3 clinical trial evaluating PA32540 for Aspirin-Associated Gastric Ulcers. Completed, enrolled 380 participants across 1 site.
Detailed Summary
This study uses an open-label design and will be conducted in approximately 40 sites in the United States. Approximately 400 subjects will be enrolled in the study to ensure that approximately 300 subjects will have 6 months exposure to PA32540 and at least 100 subjects will have 12 months exposure to PA32540.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAspirin-Associated Gastric Ulcers
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2009
First PostedOct 2009
Primary CompletionMay 2011
TodayJul 2026
First PostedOct 15, 2009
Enrollment StartOct 1, 2009
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 16.7 years ago
Interventions
PA32540drug
PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily