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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00542555
Recruitment Status : Completed
First Posted : October 11, 2007
Last Update Posted : June 17, 2011
Sponsor:
Information provided by:
NicOx

Tracking Information
First Submitted Date  ICMJE October 10, 2007
First Posted Date  ICMJE October 11, 2007
Last Update Posted Date June 17, 2011
Study Start Date  ICMJE December 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2007)
The primary objective of this study is to show that naproxcinod is superior to placebo in relieving OA signs and symptoms in subjects with OA of the knee at 13 weeks and to collect long term safety data [ Time Frame: 13 weeks / long term ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
Official Title  ICMJE 301: A Phase 3 Study of the Analgesic Efficacy and Safety of HCT 3012: A Parallel, Randomized, Double Blind, 13 Week Placebo and Naproxen Controlled, Multicenter Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Patients With Osteoarthritis of the Knee, Followed by Its Extension (301E): A Parallel, Randomized, Open-Label, Multicenter, 52-Week Follow-up Safety Study of HCT 3012 (375 mg Bid and 750 mg Bid) in Subjects With Osteoarthritis of the Knee
Brief Summary To study the efficacy and safety of naproxcinod vs. placebo and naproxen in the treatment of signs and symptoms of Osteoarthritis.
Detailed Description This is a 13-week double-blind study followed by a 52-week, open-label, roll-over on active treatment study. These are randomized, parallel group, multicenter studies comparing efficacy and safety of naproxcinod, placebo and naproxen.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Drug: Placebo
    At 13 weeks, the patients receiving placebo were re-randomized to receive either naproxcinod 375 mg bid or naproxcinod 750 mg bid in a 1:1 ratio in the 301E study.
  • Drug: Naproxcinod 375 mg
  • Drug: Naproxen
  • Drug: Naproxcinod 750 mg
Study Arms  ICMJE
  • Placebo Comparator: Placebo bid
    At 13 weeks, the patients receiving placebo were re-randomized to receive either naproxcinod 375 mg bid or naproxcinod 750 mg bid in a 1:1 ratio in the 301E study.
    Intervention: Drug: Placebo
  • Experimental: Naproxcinod 375 mg bid
    Intervention: Drug: Naproxcinod 375 mg
  • Active Comparator: Naproxen 500 mg bid
    Intervention: Drug: Naproxen
  • Experimental: Naproxcinod 750 mg bid
    Intervention: Drug: Naproxcinod 750 mg
Publications * Schnitzer TJ, Kivitz A, Frayssinet H, Duquesroix B. Efficacy and safety of naproxcinod in the treatment of patients with osteoarthritis of the knee: a 13-week prospective, randomized, multicenter study. Osteoarthritis Cartilage. 2010 May;18(5):629-39. doi: 10.1016/j.joca.2009.12.013. Epub 2010 Feb 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2007)
918
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women (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 anticoagulant
  • A history of alcohol or drug abuse
  • Candidates for imminent joint replacement
  • Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months
  • Current medical disease that could confound or interfere with the evaluation of efficacy
  • Participation within 30 days prior to screening in another investigational study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00542555
Other Study ID Numbers  ICMJE HCT3012-X-301/301E
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Dr Brigitte Duquesroix, Senior Director Clinical Research, NicOx
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE NicOx
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account NicOx
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP