Trial Information

Summary: This is a 6-month study to evaluate the incidence of gastric ulcers in subjects at high risk for developing NSAID-associated ulcers.

After meeting all entrance criteria, including an endoscopy to check for the presence of ulcers, subjects will be assigned to take either PN 400 twice a day or naproxen 500mg twice a day for 6 months. Subjects will return at 1, 3 and 6 months for safety assessments, more study drug and an endoscopy. Subjects will also be asked about dyspepsia and related GI symptoms. If either a gastric or duodenal ulcer is detected, study drug will be discontinued and subjects placed on appropriate medication for treatment.

Inclusion and Exclusion Criteria:
Male or non-pregnant female subjects, 18 years and older with a history of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis or other medical conditions expected to require daily NSAID therapy for at least 6 months, with a documented history of an ulcer related serious upper gastrointestinal event such as bleeding, perforation or obstruction.

Female subjects of childbearing potential are required to use acceptable methods of birth control.

Subjects must not have any uncontrolled acute or chronic medical illness, (e.g.; diabetes, hypertension, thyroid disorder, blood disorders, psychiatric disorders and/or infection) or have any drug dependence or overuse of narcotics for management of pain.

Subjects must not have any gastrointestinal disorder or surgery leading to impaired drug absorption or have any gastric or duodenal ulcers at the screening endoscopy. Certain concomitant medications cannot be taken while in the study.

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Trial listings updated: June 1, 2008 at 6:33:20 AM