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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 17, 2007
Last Updated Date	June 16, 2011
Start Date ^ICMJE	April 2007
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 ] [ Designated as safety issue: No ]
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	Complete list of historical versions of study NCT00504127 on ClinicalTrials.gov Archive Site
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 ] [ 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 ]
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 Arm (s)	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
Enrollment ^ICMJE	1020
Completion Date	Not Provided
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
Gender	Both
Ages	40 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00504127
Other Study ID Numbers ^ICMJE	HCT 3012-X-302
Has Data Monitoring Committee	Yes
Responsible Party	Dr Brigitte Duquesroix, senior Director of Clinical Research, nicox
Study Sponsor ^ICMJE	NicOx
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	NicOx
Verification Date	June 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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