Analgesic 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:
NCT00542555
First received: October 10, 2007
Last updated: June 16, 2011
Last verified: June 2011

October 10, 2007
June 16, 2011
December 2005
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00542555 on ClinicalTrials.gov Archive Site
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Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
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

To study the efficacy and safety of naproxcinod vs. placebo and naproxen in the treatment of signs and symptoms of Osteoarthritis.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis
  • 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
  • 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
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. PubMed PMID: 20202489.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
918
September 2007
Not Provided

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00542555
HCT3012-X-301/301E
Yes
Dr Brigitte Duquesroix, Senior Director Clinical Research, NicOx
NicOx
Not Provided
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NicOx
June 2011

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