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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

NCT00961350 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 530

Last updated 2016-02-18

Study results available
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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

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)

Sponsors & Collaborators

  • POZEN

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00961350 on ClinicalTrials.gov