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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: NCT00504127
Recruitment Status : Completed
First Posted : July 19, 2007
Last Update Posted : June 17, 2011
Sponsor:
Information provided by:
NicOx

Tracking Information
First Submitted Date  ICMJE July 17, 2007
First Posted Date  ICMJE July 19, 2007
Last Update Posted Date June 17, 2011
Study Start Date  ICMJE April 2007
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2011)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2007)
To show that Naproxcinod is superior to placebo in relieving OA signs and symptoms in subjects with OA of the knee [ Time Frame: 13 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2011)
  • 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 ]
  • 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 ]
  • To obtain information regarding the pharmacokinetics/exposure of both doses of naproxcinod through a population pharmacokinetics (PK) approach [ Time Frame: 52 weeks ]
  • 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 ]
  • 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 ]
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 Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
Official Title  ICMJE 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
Brief Summary To study of efficacy and safety of Naproxcinod vs. Naproxen and Placebo in the indication of signs and symptoms of osteoarthritis
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.
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: Naproxcinod 375 mg bid
    Naproxcinod 375 mg bid
  • Drug: Naproxcinod 750 mg bid
    Naproxcinod 750 mg bid
  • Drug: Naproxen 500 mg bid
    Naproxen 500 mg bid
  • Drug: placebo
    placebo
Study Arms  ICMJE
  • Experimental: naproxcinod 375 mg bid
    Intervention: Drug: Naproxcinod 375 mg bid
  • Experimental: naproxcinod 750 mg bid
    Intervention: Drug: Naproxcinod 750 mg bid
  • Active Comparator: naproxen 500 mg bid
    Intervention: Drug: Naproxen 500 mg bid
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   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: July 17, 2007)
1020
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00504127
Other Study ID Numbers  ICMJE HCT 3012-X-302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Brigitte Duquesroix, senior Director of Clinical Research, nicox
Study Sponsor  ICMJE NicOx
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