Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
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
1 other identifier
interventional
1,020
1 country
73
Brief Summary
To study of efficacy and safety of Naproxcinod vs. Naproxen and Placebo in the indication 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
73 active sites
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
April 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 17, 2007
CompletedFirst Posted
Study publicly available on registry
July 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedJune 17, 2011
June 1, 2011
1.7 years
July 17, 2007
June 16, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
13 weeks
Secondary Outcomes (5)
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
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
52 weeks
To obtain information regarding the pharmacokinetics/exposure of both doses of naproxcinod through a population pharmacokinetics (PK) approach
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)
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)
53 weeks
Study Arms (4)
naproxcinod 375 mg bid
EXPERIMENTALnaproxcinod 750 mg bid
EXPERIMENTALnaproxen 500 mg bid
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NicOxlead
Study Sites (73)
Unknown Facility
Chandler, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Encino, California, United States
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Foothill Ranch, California, United States
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Orange, California, United States
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Rancho Mirage, California, United States
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Riverside, California, United States
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Denver, Colorado, United States
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Waterbury, Connecticut, United States
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Boca Raton, Florida, United States
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Brooksville, Florida, United States
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DeLand, Florida, United States
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Jacksonville, Florida, United States
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Largo, Florida, United States
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Ocala, Florida, United States
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Pinellas Park, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Chicago, Illinois, United States
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Rockford, Illinois, United States
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Prairie Village, Kansas, United States
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Wichita, Kansas, United States
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Erlanger, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Owings Mills, Maryland, United States
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Wellesley Hills, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Brooklyn Center, Minnesota, United States
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Edina, Minnesota, United States
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Florissant, Missouri, United States
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St Louis, Missouri, United States
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Rochester, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Concord, North Carolina, United States
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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Beachwood, Ohio, United States
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Columbus, Ohio, United States
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Marion, Ohio, United States
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Clinton, Oklahoma, United States
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Altoona, Pennsylvania, United States
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Bensalem, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Anderson, South Carolina, United States
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Clinton, South Carolina, United States
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Goose Creek, South Carolina, United States
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Greer, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Cordova, Tennessee, United States
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Jackson, Tennessee, United States
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Kingsport, Tennessee, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Garland, Texas, United States
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Houston, Texas, United States
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Nederland, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Norfolk, Virginia, United States
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Roanoke, Virginia, United States
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Virginia Beach, Virginia, United States
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Lakewood, Washington, United States
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
July 17, 2007
First Posted
July 19, 2007
Study Start
April 1, 2007
Primary Completion
December 1, 2008
Last Updated
June 17, 2011
Record last verified: 2011-06