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

Study Overview
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Brief Summary
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To study the efficacy and safety of naproxcinod vs. placebo and naproxen in the treatment of signs and symptoms of Osteoarthritis.

Detailed Description
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This is a 13-week double-blind study followed by a 52-week, open-label, roll-over on active treatment study. These are randomized, parallel group, multicenter studies comparing efficacy and safety of naproxcinod, placebo and naproxen.

Official Title
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301: A Phase 3 Study of the Analgesic Efficacy and Safety of HCT 3012: A Parallel, Randomized, Double Blind, 13 Week Placebo and Naproxen Controlled, Multicenter Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Patients With Osteoarthritis of the Knee, Followed by Its Extension (301E): A Parallel, Randomized, Open-Label, Multicenter, 52-Week Follow-up Safety Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Subjects With Osteoarthritis of the Knee

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Placebo
* Drug: Naproxcinod 375 mg
* Drug: Naproxen
* Drug: Naproxcinod 750 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women (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 anticoagulant A history of alcohol or drug abuse Candidates for imminent joint replacement Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months Current medical disease that could confound or interfere with the evaluation of efficacy Participation within 30 days prior to screening in another investigational study

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo bid<br>At 13 weeks, the patients receiving placebo were re-randomized to receive either naproxcinod 375 mg bid or naproxcinod 750 mg bid in a 1:1 ratio in the 301E study. | Drug: Placebo<br>* At 13 weeks, the patients receiving placebo were re-randomized to receive either naproxcinod 375 mg bid or naproxcinod 750 mg bid in a 1:1 ratio in the 301E study.<br>|
| Experimental: Naproxcinod 375 mg bid<br> | Drug: Naproxcinod 375 mg<br> <br> |
| Active Comparator: Naproxen 500 mg bid<br> | Drug: Naproxen<br> <br> |
| Experimental: Naproxcinod 750 mg bid<br> | Drug: Naproxcinod 750 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 knee at 13 weeks and to collect long term safety data |  | 13 weeks / long term |