Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00960869 · ClinicalTrials.gov registry record · Phase 3
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
- 519
- Enrollment target
NCT00960869: Completed Phase 3 study, sponsored by POZEN.
NCT00960869 is a Phase 3 study that has completed, run by POZEN. The registered enrollment target is 519 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00960869, a Phase 3 study, has completed, sponsored by POZEN.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 519 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 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 519 participants |
| Start Date | 2009-10 |
| Est. Completion | 2012-02 |
| Phase | Phase 3 |
What the finished NCT00960869 record still lists
NCT00960869 is an interventional study that assigns participants to a tested intervention. The registered 519 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 (33% lower).
The record links to 0 conditions, and to 2 interventions - of which PA32540 is the first listed.
NCT00960869 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00960869 about?
NCT00960869 is a clinical study titled "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 NCT00960869?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 519 participants. The study started on 2009-10. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00960869?
The interventions under investigation include: PA32540 (DRUG), EC-Aspirin 325 mg (DRUG).
Who is sponsoring clinical trial NCT00960869?
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 NCT00960869's enrollment target sits among peer trials
519 723rd of 2000 higher than 1,278 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02323581 · 520 participants · NA
Endovascular Treatment of TAAA and Aortic Arch Aneurysms Using Fenestrated and Branched Stent Grafts
- NCT04656496 · 520 participants · NA
NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors
- NCT05445778 · 520 participants · Phase 3
Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
- NCT05498428 · 520 participants · Phase 2
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia