Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip
Phase 3
Completed
- Conditions
- OsteoarthritisOsteoarthritis, Hip
- Interventions
- Registration Number
- NCT00541489
- Lead Sponsor
- NicOx
- Brief Summary
To study the efficacy and safety of Naproxcinod vs. Placebo and Naproxen in the treatment of signs and symptoms of Osteoarthritis.
- Detailed Description
This is a 13 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Naproxen Naproxen 500 mg 3 Naproxcinod Naproxcinod 750 mg 1 Placebo -
- Primary Outcome Measures
Name Time Method The primary objective of this study is to show that Naproxcinod is superior to placebo in relieving OA signs and symptoms in subjects with OA of the hip
- Secondary Outcome Measures
Name Time Method