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

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

Summary

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