Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip

This is a 13 week randomized, double-blind, parallel group, multicenter study 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 hip

- 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

- Clinically relevant abnormal ECG

- A history of alcohol or drug abuse

- Diagnosis of gastric or duodenal ulceration and/or history of significant
gastro‑duodenal bleeding, within the last 6 months

- Current medical disease, including arthritic, that could confound or interfere with
the evaluation of efficacy

- Candidates for imminent joint replacement

- Participation within 30 days prior to screening in another investigational study