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

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ClinicalTrials.gov Identifier: NCT00504127
Recruitment Status : Completed
First Posted : July 19, 2007
Last Update Posted : June 17, 2011
Information provided by:

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

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Naproxcinod 375 mg bid Drug: Naproxcinod 750 mg bid Drug: Naproxen 500 mg bid Drug: placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1020 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2007
Actual Primary Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: naproxcinod 375 mg bid Drug: Naproxcinod 375 mg bid
Naproxcinod 375 mg bid

Experimental: naproxcinod 750 mg bid Drug: Naproxcinod 750 mg bid
Naproxcinod 750 mg bid

Active Comparator: naproxen 500 mg bid Drug: Naproxen 500 mg bid
Naproxen 500 mg bid

Placebo Comparator: placebo Drug: placebo

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504127

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Sponsors and Collaborators
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Responsible Party: Dr Brigitte Duquesroix, senior Director of Clinical Research, nicox
ClinicalTrials.gov Identifier: NCT00504127    
Other Study ID Numbers: HCT 3012-X-302
First Posted: July 19, 2007    Key Record Dates
Last Update Posted: June 17, 2011
Last Verified: June 2011
Keywords provided by NicOx:
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen-n-butyl nitrate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nitric Oxide Donors