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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NicOx
• Treatments: Naproxen; Naproxen-n-butyl nitrate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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