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

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis, Osteoarthritis, Hip

In brief

To study the efficacy and safety of Naproxcinod vs. Placebo and Naproxen in the treatment of signs and symptoms of Osteoarthritis.

Key facts

Study ID

NCT00541489

Run by

NicOx

People needed

800

Starts

2007-06-01

Last updated by the study team

2009-02-20

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Louisville, Kentucky, United States
• Study site — Peabody, Massachusetts, United States
• Study site — Kalamazoo, Michigan, United States
• Study site — Saginaw, Michigan, United States
• Study site — Berlin, New Jersey, United States
• Study site — Dover, New Jersey, United States
• Study site — Rochester, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Franklin, Ohio, United States
• Study site — Bethany, Oklahoma, United States
• Study site — Duncansville, Pennsylvania, United States
• Study site — Penndel, Pennsylvania, United States
• Study site — Warwick, Rhode Island, United States
• Study site — Anderson, South Carolina, United States
• Study site — Columbia, South Carolina, United States
• Study site — Kingsport, Tennessee, United States
• Study site — Austin, Texas, United States
• Study site — Nederland, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Newport News, Virginia, United States
• Study site — Burnaby, British Columbia, Canada
• Study site — Coquitlam, British Columbia, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Corunna, Ontario, Canada

Full record on ClinicalTrials.gov

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