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

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis

In brief

To study of efficacy and safety of Naproxcinod vs. Naproxen and Placebo in the indication of signs and symptoms of osteoarthritis

Key facts

Study ID

NCT00504127

Run by

NicOx

People needed

1020

Starts

2007-04-01

Last updated by the study team

2011-06-17

Who can join

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

You may qualify if…

• Men and Woman (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

You may not qualify if…

• Uncontrolled Hypertension or Diabetes
• Hepatic or Renal Impairment
• Current or expected use of anti-coagulant
• Clinical relevant abnormal ECG
• A history of alcohol or drug abuse
• Candidates for imminent joint replacement
• Participation within 30 days prior to screening in another investigational study

Where it is running

• Study site — Tempe, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Encino, California, United States
• Study site — Foothill Ranch, California, United States
• Study site — Orange, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — Riverside, California, United States
• Study site — Denver, Colorado, United States
• Study site — Waterbury, Connecticut, United States
• Study site — Boca Raton, Florida, United States
• Study site — Brooksville, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Largo, Florida, United States
• Study site — Ocala, Florida, United States
• Study site — Pinellas Park, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Athens, Georgia, United States
• Study site — Atlanta, Georgia, United States
• Study site — Marietta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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