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Completed

NCT Number: NCT00504127

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

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

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chandler, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naproxcinod 375 mg bid

Drug

Naproxcinod 375 mg bid

Naproxcinod 750 mg bid

Drug

Naproxcinod 750 mg bid

naproxen 500 mg bid

Drug

Naproxen 500 mg bid

Placebo

Drug

placebo

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. To obtain information regarding the pharmacokinetics/exposure of both doses of naproxcinod through a population pharmacokinetics (PK) approach

    Time frame: 52 weeks

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

NicOx

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
First posted
Jul 19, 2007
Registry last updated
Jun 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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