CompletedPhase 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

United States519 participantsStarted 2009-10

Plain-language 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.

Who can participate

Age range55 Years

SexALL

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Inclusion criteria

✓. A. Male or non-pregnant, non-breastfeeding females who have been on daily aspirin 325 mg for at least three months and who are expected to use daily aspirin 325 mg for at least six months (Daily is defined as "at least 5 days per week"):
✓. A. Aspirin use should be for the secondary prevention of cardiovascular or cerebrovascular events as defined as follows:
✓. A. If female, subjects are eligible if they are of
✓. non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
✓. childbearing potential, have a negative pregnancy test at screening, and at least one of the following applies or is agreed to by the subject:

Exclusion criteria

✕. Baseline endoscopy showing any gastric, esophageal or duodenal ulcer at least 3 mm in diameter with depth
✕. Positive test result for H. pylori at screening 3A. Have had a revascularization procedure (i.e., Coronary Artery Bypass Graft, Percutaneous Transluminal Coronary Angioplasty, or carotid endarterectomy) less than six months prior to screening

What they're measuring

Number of Participants With Gastric Ulcer Confirmed by Endoscopy

Timeframe: 6 months

Trial details

NCT IDNCT00960869

SponsorPOZEN

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-02

Results submitted2015-10-22

View on ClinicalTrials.gov More Gastric Ulcer trials