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 |
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.
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.
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
We found this trial at
37
sites
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