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

Phase 3

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Placebo; Drug: Naproxcinod 375 mg; Drug: Naproxcinod 750 mg; Drug: Naproxen

• Registration Number: NCT00542555
• 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 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.

Study Timeline

• Study Start: 2005-12
• Study Completion: 2007-09
• Study First Submitted: 2007-10-10
• Study First Submitted QC: 2007-10-10
• Study First Posted: 2007-10-11
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-16
• Last Update Posted: 2011-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 918

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo bid	Placebo	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.
Naproxcinod 375 mg bid	Naproxcinod 375 mg	-
Naproxcinod 750 mg bid	Naproxcinod 750 mg	-
Naproxen 500 mg bid	Naproxen	-

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 knee at 13 weeks and to collect long term safety data	13 weeks / long term