Tolerability and Efficacy of Ibuprofen 800 mg in a Walking Model of Osteoarthritis Pain (0000-057)

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to see if generic ibuprofen has an effect on osteoarthritis knee pain during a series of timed walks on a treadmill.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ibuprofen

Criteria

Inclusion Criteria:

• The primary source of pain is the study knee of one lower extremity

• Patient is willing to limit alcohol and caffeine intake

• Aside from osteoarthritis, patient is in generally good health

• Patient is capable of completing protocol specified walks

• Patient is able to understand and complete questionnaires in English

• Patient has previously benefited from the use of either NSAIDs, COX-2 inhibitors, or acetaminophen

Exclusion Criteria:

• Patient has another condition which could interfere with evaluating pain in the knee being tested

• Patient is not able to take a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen

• Patient has a history or current evidence of stroke, transient ischemic attack, liver disease or cancer

• Patient has a history or current evidence of dizziness, unsteadiness, or falling

• Patient has congestive heart failure, unstable angina or uncontrolled high blood pressure

• Patient has a history of stomach, digestive track, or small intestine surgery

• Patient is unable to complete the study questionnaires in English