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

A Randomized, Placebo-Controlled Single-Dose 3-Period Crossover Study to Assess the Tolerability and Efficacy of Ibuprofen 800 mg in a Walking Model of Osteoarthritis Pain

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.

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