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

Phase 3

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Naproxcinod 750 mg bid; Drug: Naproxcinod 375 mg bid; Drug: Naproxen 500 mg bid; Drug: placebo

• Registration Number: NCT00504127
• Lead Sponsor: NicOx

Brief Summary

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

Detailed Description

This is a 53 week study consisting in a 26 week randomized, double-blind, parallel group, multicenter study comparing efficacy and safety of Naproxcinod, Placebo and Naproxen. The first 26 weeks will be followed by a naproxen-controlled treatment period up to 52 weeks and a 1-week post-treatment safety follow-up.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-07-17
• Study First Submitted QC: 2007-07-17
• Study First Posted: 2007-07-19
• Primary Completion: 2008-12
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-16
• Last Update Posted: 2011-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1020

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
naproxcinod 750 mg bid	Naproxcinod 750 mg bid	-
naproxcinod 375 mg bid	Naproxcinod 375 mg bid	-
naproxen 500 mg bid	Naproxen 500 mg bid	-
placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
To show that both doses of Naproxcinod (375 mg twice daily [bid] and 750 mg bid) were superior to placebo in relieving osteoarthritis (OA) signs and symptoms in subjects with OA of the knee at Week 13.	13 weeks

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of naproxcinod compared to naproxen 500 mg bid in relieving OA signs and symptoms in subjects with OA of the knee	52 weeks
To evaluate the effect on blood pressure (BP) of both doses of naproxcinod, placebo, and naproxen 500 mg bid, as measured by the office BP monitoring in a population of OA subjects	52 weeks
To obtain information regarding the pharmacokinetics/exposure of both doses of naproxcinod through a population pharmacokinetics (PK) approach	52 weeks
To assess if there were any radiological changes at Week 52 in naproxcinod compared with naproxen subjects (target joint radiographs were taken at Screening and after 52 weeks of treatment, or if early termination occurred after Week 26)	52 weeks
To compare the general safety and tolerability of both doses of naproxcinod versus naproxen 500 mg bid up to 52 weeks and with one Week post treatment follow up (Week 53)	53 weeks