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NCT00961350 · ClinicalTrials.gov registry record · Phase 3
A 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
A Phase 3 study, sponsored by POZEN.
- Completed
- Registry status
- Phase 3
- Development phase
- 530
- Enrollment target
NCT00961350: Completed Phase 3 study, sponsored by POZEN.
NCT00961350 is a Phase 3 study that has completed, run by POZEN. The registered enrollment target is 530 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00961350, a Phase 3 study, has completed, sponsored by POZEN.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 530 participants
- Enrollment target
Study 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.
Primary Outcome
The primary efficacy endpoint was the number of subjects with gastric ulcers at any time throughout 6 months of treatment. An ulcer was defined as a mucosal break of at least 3 mm in diameter (measured by close application of open endoscopic biopsy forceps) with unequivocal crater depth. A subject is considered to have completed the study if all scheduled assessments up through the 6 month visit have been performed or if the endpoint of gastric ulcer confirmed by endoscopy has been reached.
Interventions
- DRUG PA32540
- DRUG EC Aspirin 325
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 530 participants |
| Start Date | 2009-10 |
| Est. Completion | 2012-02 |
| Phase | Phase 3 |
What the finished NCT00961350 record still lists
NCT00961350 is an interventional study that assigns participants to a tested intervention. The registered 530 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 2 interventions - of which PA32540 is the first listed.
NCT00961350 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00961350 about?
NCT00961350 is a clinical study titled "A 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". 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.
What is the current status of trial NCT00961350?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 530 participants. The study started on 2009-10. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00961350?
The interventions under investigation include: PA32540 (DRUG), EC Aspirin 325 (DRUG).
Who is sponsoring clinical trial NCT00961350?
This trial is sponsored by POZEN, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00961350's enrollment target sits among peer trials
530 706th of 2000 higher than 1,292 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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