Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip
NCT ID: NCT00541489
Last Updated: 2009-02-20
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
800 participants
INTERVENTIONAL
2007-06-30
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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1
Placebo
bid
2
Naproxen 500 mg
Naproxen
500 mg, bid
3
Naproxcinod 750 mg
Naproxcinod
750 mg, bid
Interventions
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Naproxcinod
750 mg, bid
Naproxen
500 mg, bid
Placebo
bid
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 anticoagulant
* Clinically relevant abnormal ECG
* A history of alcohol or drug abuse
* Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding, within the last 6 months
* Current medical disease, including arthritic, that could confound or interfere with the evaluation of efficacy
* 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
Locations
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Mobile, Alabama, United States
Montgomery, Alabama, United States
Tuscaloosa, Alabama, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Fair Oaks, California, United States
San Diego, California, United States
Santa Barbara, California, United States
Northglenn, Colorado, United States
Coral Gables, Florida, United States
Daytona Beach, Florida, United States
DeLand, Florida, United States
Fort Meyers, Florida, United States
Jupiter, Florida, United States
Louisville, Kentucky, United States
Peabody, Massachusetts, United States
Kalamazoo, Michigan, United States
Saginaw, Michigan, United States
Berlin, New Jersey, United States
Dover, New Jersey, United States
Rochester, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Franklin, Ohio, United States
Bethany, Oklahoma, United States
Duncansville, Pennsylvania, United States
Penndel, Pennsylvania, United States
Warwick, Rhode Island, United States
Anderson, South Carolina, United States
Columbia, South Carolina, United States
Kingsport, Tennessee, United States
Austin, Texas, United States
Nederland, Texas, United States
San Antonio, Texas, United States
Newport News, Virginia, United States
Burnaby, British Columbia, Canada
Coquitlam, British Columbia, Canada
Vancouver, British Columbia, Canada
Corunna, Ontario, Canada
Kitchener, Ontario, Canada
Mississauga, Ontario, Canada
Newmarket, Ontario, Canada
Toronto, Ontario, Canada
Québec, Quebec, Canada
Trois-Rivières, Quebec, Canada
Regina, Saskatchewan, Canada
Saskatoon, Saskatchewan, Canada
Countries
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References
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Baerwald C, Verdecchia P, Duquesroix B, Frayssinet H, Ferreira T. Efficacy, safety, and effects on blood pressure of naproxcinod 750 mg twice daily compared with placebo and naproxen 500 mg twice daily in patients with osteoarthritis of the hip: a randomized, double-blind, parallel-group, multicenter study. Arthritis Rheum. 2010 Dec;62(12):3635-44. doi: 10.1002/art.27694.
Related Links
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Click here to learn more about this study - Efficacy and Safety Study of Naproxcinod in Subjects with Osteoarthritis of the Hip
Other Identifiers
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HCT3012-X-303
Identifier Type: -
Identifier Source: org_study_id
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