Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee

301: A Phase 3 Study of the Analgesic Efficacy and Safety of HCT 3012: A Parallel, Randomized, Double Blind, 13 Week Placebo and Naproxen Controlled, Multicenter Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Patients With Osteoarthritis of the Knee, Followed by Its Extension (301E): A Parallel, Randomized, Open-Label, Multicenter, 52-Week Follow-up Safety Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Subjects With Osteoarthritis of the Knee

To study the efficacy and safety of naproxcinod vs. placebo and naproxen in the treatment of signs and symptoms of Osteoarthritis.

This is a 13-week double-blind study followed by a 52-week, open-label, roll-over on active treatment study. These are randomized, parallel group, multicenter studies comparing efficacy and safety of naproxcinod, placebo and naproxen.

Inclusion Criteria:

• Men and women (40 or older) with a diagnosis of primary OA of the knee
• Must be a current chronic user of NSAIDS or acetaminophen
• Must discontinue all analgesic therapy at screening

Exclusion Criteria:

• Uncontrolled hypertension or diabetes
• Hepatic or renal impairment
• Current or expected use of anticoagulant
• A history of alcohol or drug abuse
• Candidates for imminent joint replacement
• Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months
• Current medical disease that could confound or interfere with the evaluation of efficacy
• Participation within 30 days prior to screening in another investigational study