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
1 other identifier
interventional
918
0 countries
N/A
Brief Summary
To study the efficacy and safety of naproxcinod vs. placebo and naproxen in the treatment of signs and symptoms of Osteoarthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2005
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 10, 2007
CompletedFirst Posted
Study publicly available on registry
October 11, 2007
CompletedJune 17, 2011
June 1, 2011
October 10, 2007
June 16, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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
13 weeks / long term
Study Arms (4)
Placebo bid
PLACEBO COMPARATORAt 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.
Naproxcinod 375 mg bid
EXPERIMENTALNaproxen 500 mg bid
ACTIVE COMPARATORNaproxcinod 750 mg bid
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NicOxlead
Related Publications (1)
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.
PMID: 20202489DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 10, 2007
First Posted
October 11, 2007
Study Start
December 1, 2005
Study Completion
September 1, 2007
Last Updated
June 17, 2011
Record last verified: 2011-06