Trial Information

Summary: This is a 12-month study to provide long-term safety data for subjects at risk for developing NSAID-associated upper gastrointestinal ulcers

After meeting all entrance criteria, including an endoscopy to check for the presence of ulcers, subjects will be assigned to take PN 400 twice a day for 12 months. Subjects will return at 1, 3, 6 and 9 months for safety assessments and more study drug. Subjects completing 12 months of therapy will return for a final visit for safety assessments.

Inclusion and Exclusion Criteria:
Male or non-pregnant, non-breastfeeding female subjects with a history of osteoarthritis rheumatoid arthritis, ankylosing spondylitis or other medical conditions expected to require daily NSAID therapy for at least 6 months who are:

• 18-49 years of age and have a history of a documented, uncomplicated gastric or duodenal ulcer (a mucosal break of at least 3 mm in diameter with depth, without any concurrent bleeding, clot or perforation) within the past 5 years

OR, who are

• 50 years of age and older (these subjects do not require a history of a documented, uncomplicated gastric or duodenal ulcer within the past 5 years)

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.

www.PainResearchStudies.com

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: November 24, 2008 at 2:07:55 PM