Back to resultsAnalgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
Naproxcinod 375 mg
Naproxen
Naproxcinod 750 mg
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Active Comparator
Experimental
Arm Label
Placebo bid
Naproxcinod 375 mg bid
Naproxen 500 mg bid
Naproxcinod 750 mg bid
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00542555
Brief Title
Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
NicOx
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
918 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo bid
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Naproxcinod 375 mg bid
Arm Type
Experimental
Arm Title
Naproxen 500 mg bid
Arm Type
Active Comparator
Arm Title
Naproxcinod 750 mg bid
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Type
Drug
Intervention Name(s)
Naproxcinod 375 mg
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Type
Drug
Intervention Name(s)
Naproxcinod 750 mg
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
20202489
Citation
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.
Results Reference
derived
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Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
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