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



Status:Completed
Conditions:Arthritis, Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:40 - Any
Updated:10/14/2017
Start Date:June 2007

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A 13-Week, Phase 3, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Bid and Naproxen 500 mg Bid, Controlled Study on the Efficacy on Signs and Symptoms, and Safety of Naproxcinod (HCT3012) 750 mg Bid, in Patients With Osteoarthritis of the Hip

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 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
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