A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain (0000-105)(COMPLETED)

A Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Evaluate the Analgesic Effects of Naproxen and Ultracet in a Walking Model of Osteoarthritis Knee Pain

This study will evaluate a walking model of osteoarthritis for use in testing of new therapeutic agents. The primary hypothesis is that participants treated with Naproxen or Ultracet will have lower Pain Intensity (PI) than those treated with Placebo during self-paced walks on Day 3 of treatment.

Inclusion Criteria:

• Has osteoarthritis of the knee and primary source of pain is knee
• Females must not be pregnant or nursing and must agree to use birth control throughout the study
• Is willing to limit alcohol and caffeine intake
• Is willing to abstain from smoking during study visits
• Must be able to walk on a treadmill at a pace of at least 1 mile/hour

Exclusion Criteria:

• Has a medical/arthritic disease that would interfere with evaluation
• Is unable to take naproxen or Ultracet
• Has congestive heart failure or angina
• Has a history of stroke
• Has a history of uncontrolled high blood pressure
• Has a history of cancer
• Regularly uses a walker or cane