Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee
NCT ID: NCT00504127
Last Updated: 2011-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1020 participants
INTERVENTIONAL
2007-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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naproxcinod 375 mg bid
Naproxcinod 375 mg bid
Naproxcinod 375 mg bid
naproxcinod 750 mg bid
Naproxcinod 750 mg bid
Naproxcinod 750 mg bid
naproxen 500 mg bid
Naproxen 500 mg bid
Naproxen 500 mg bid
placebo
placebo
placebo
Interventions
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Naproxcinod 375 mg bid
Naproxcinod 375 mg bid
Naproxcinod 750 mg bid
Naproxcinod 750 mg bid
Naproxen 500 mg bid
Naproxen 500 mg bid
placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* Must be a current chronic user of NSAIDS or acetaminophen
* Must discontinue all analgesic therapy at Screening
Exclusion Criteria
* 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
40 Years
ALL
No
Sponsors
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NicOx
INDUSTRY
Responsible Party
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nicox
Locations
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Chandler, Arizona, United States
Tempe, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Encino, California, United States
Foothill Ranch, California, United States
Orange, California, United States
Rancho Mirage, California, United States
Riverside, California, United States
Denver, Colorado, United States
Waterbury, Connecticut, United States
Boca Raton, Florida, United States
Brooksville, Florida, United States
DeLand, Florida, United States
Jacksonville, Florida, United States
Largo, Florida, United States
Ocala, Florida, United States
Pinellas Park, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Athens, Georgia, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Rockford, Illinois, United States
Prairie Village, Kansas, United States
Wichita, Kansas, United States
Erlanger, Kentucky, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Owings Mills, Maryland, United States
Wellesley Hills, Massachusetts, United States
Ann Arbor, Michigan, United States
Brooklyn Center, Minnesota, United States
Edina, Minnesota, United States
Florissant, Missouri, United States
St Louis, Missouri, United States
Rochester, New York, United States
Asheville, North Carolina, United States
Charlotte, North Carolina, United States
Concord, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Winston-Salem, North Carolina, United States
Beachwood, Ohio, United States
Columbus, Ohio, United States
Marion, Ohio, United States
Clinton, Oklahoma, United States
Altoona, Pennsylvania, United States
Bensalem, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
West Reading, Pennsylvania, United States
Anderson, South Carolina, United States
Clinton, South Carolina, United States
Goose Creek, South Carolina, United States
Greer, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Cordova, Tennessee, United States
Jackson, Tennessee, United States
Kingsport, Tennessee, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Garland, Texas, United States
Houston, Texas, United States
Nederland, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Roanoke, Virginia, United States
Virginia Beach, Virginia, United States
Lakewood, Washington, United States
Countries
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Other Identifiers
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HCT 3012-X-302
Identifier Type: -
Identifier Source: org_study_id
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