NCT00961350View on ClinicalTrials.gov

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

PHASE3CompletedINTERVENTIONAL
Enrollment

530

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

February 29, 2012

Study Completion Date

February 29, 2012

Conditions
Gastric Ulcer
Interventions
DRUG

PA32540

PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole

DRUG

EC Aspirin 325

The comparator aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole)

Trial Locations (1)

27519

Pozen, Chapel Hill

Sponsors

Lead Sponsor

POZEN
All Listed Sponsors
lead

POZEN

INDUSTRY

NCT00961350 - 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 | Biotech Hunter | Biotech Hunter