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

Overview

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

Full Title of Study: “A Phase 3, 53 Weeks Study on Analgesic Efficacy and Safety of Naproxcinod (HCT 3012): 26-Week, Randomized, Parallel-Group, Double-Blind, Placebo (13 Weeks)- and Naproxen (26 Weeks)-Controlled, Multicenter Study of Naproxcinod (375 mg Bid and 750 mg Bid) With a 26-Week Naproxen-Controlled Safety Follow-up in Subjects With Osteoarthritis of the Knee, and a 1-week Post-treatment Safety Follow-up”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2008

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.

Interventions

  • Drug: Naproxcinod 375 mg bid
    • Naproxcinod 375 mg bid
  • Drug: Naproxcinod 750 mg bid
    • Naproxcinod 750 mg bid
  • Drug: Naproxen 500 mg bid
    • Naproxen 500 mg bid
  • Drug: placebo
    • placebo

Arms, Groups and Cohorts

  • Experimental: naproxcinod 375 mg bid
  • Experimental: naproxcinod 750 mg bid
  • Active Comparator: naproxen 500 mg bid
  • Placebo Comparator: placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: 13 weeks

Secondary Measures

  • 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
    • Time Frame: 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
    • Time Frame: 52 weeks
  • To obtain information regarding the pharmacokinetics/exposure of both doses of naproxcinod through a population pharmacokinetics (PK) approach
    • Time Frame: 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)
    • Time Frame: 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)
    • Time Frame: 53 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NicOx
  • Provider of Information About this Clinical Study
    • Dr Brigitte Duquesroix, senior Director of Clinical Research, nicox

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.