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

This study has been completed.
Sponsor:
Information provided by:
NicOx
ClinicalTrials.gov Identifier:
NCT00504127
First received: July 17, 2007
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Osteoarthritis
Drug: Naproxcinod 375 mg bid
Drug: Naproxcinod 750 mg bid
Drug: Naproxen 500 mg bid
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by NicOx:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To obtain information regarding the pharmacokinetics/exposure of both doses of naproxcinod through a population pharmacokinetics (PK) approach [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 1020
Study Start Date: April 2007
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
placebo

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504127

  Show 73 Study Locations
Sponsors and Collaborators
NicOx
  More Information

No publications provided

Responsible Party: Dr Brigitte Duquesroix, senior Director of Clinical Research, nicox
ClinicalTrials.gov Identifier: NCT00504127     History of Changes
Other Study ID Numbers: HCT 3012-X-302
Study First Received: July 17, 2007
Last Updated: June 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by NicOx:
Arthritis
Degenerative

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Naproxen-n-butyl nitrate
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Nitric Oxide Donors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014