NCT00960869

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 6-Month, Phase 3, Randomized, Double-Blind, Parallel-Group, Controlled, Multi-Center 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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 519 (actual)
• Sponsor: POZEN · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Ulcer

Interventions

Type	Name	Description
DRUG	PA32540	PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole
DRUG	EC-Aspirin 325 mg	The comparator aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole)

Timeline

• Start date: 2009-10-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2009-08-18
• Last updated: 2016-02-17
• Results posted: 2016-02-17

Locations

1 site across 1 country: United States