Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers.

PHASE3CompletedINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

September 30, 2007

Study Completion Date

September 30, 2007

Conditions
OsteoarthritisRheumatoid ArthritisAnkylosing Spondylitis
Interventions
DRUG

PN 200 tablets (500 mg naproxen and 20 mg omeprazole)

DRUG

Naproxen 500 mg tablets (PN 200 minus omeprazole)

Trial Locations (1)

33069

Patient Interaction, Pompano Beach

Sponsors

Lead Sponsor

All Listed Sponsors
lead

POZEN

INDUSTRY