Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients
NCT ID: NCT00650455
Last Updated: 2008-07-21
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
PHASE4
489 participants
INTERVENTIONAL
2003-02-28
2005-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 2
naproxen
naproxen 500 mg capsule twice daily for 12 weeks
Arm 3
placebo
placebo tablet every morning and capsule every evening for 12 weeks
Arm 1
valdecoxib
valdecoxib 10 mg tablet once daily for 12 weeks
Interventions
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valdecoxib
valdecoxib 10 mg tablet once daily for 12 weeks
naproxen
naproxen 500 mg capsule twice daily for 12 weeks
placebo
placebo tablet every morning and capsule every evening for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* The Rheumatoid Arthritis must have been treated with a stable regimen including a non-steroidal anti-inflammatory drug (NSAID), as well as methotrexate for at least 12 weeks -OR- an NSAID (for at least 12 weeks plus a tumor necrosis factor inhibitor (i.e., adalimumab \[Humira®\] for a minimum of 5 doses on a regular schedule, etanercept \[Enbrel®\] for 6 weeks, infliximab (Remicade®) for 3 doses and currently on a stable regimen of infusions not more than every 8 weeks)
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Birmingham, Alabama, United States
Pfizer Investigational Site
Huntsville, Alabama, United States
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Glendale, Arizona, United States
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Paradise Valley, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Fullerton, California, United States
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Rancho Mirage, California, United States
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San Diego, California, United States
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Fort Lauderdale, Florida, United States
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Jacksonville, Florida, United States
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Jupiter, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Zephyrhills, Florida, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Springfield, Illinois, United States
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Indianapolis, Indiana, United States
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Frederick, Maryland, United States
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Greenbelt, Maryland, United States
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Lansing, Michigan, United States
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Jackson, Mississippi, United States
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Marlton, New Jersey, United States
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Passaic, New Jersey, United States
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Teaneck, New Jersey, United States
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Brooklyn, New York, United States
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New York, New York, United States
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New York, New York, United States
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Columbus, Ohio, United States
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Allentown, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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Erie, Pennsylvania, United States
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Johnstown, Pennsylvania, United States
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Mechanicsburg, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadephia, Pennsylvania, United States
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Providence, Rhode Island, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Arlington, Virginia, United States
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Seattle, Washington, United States
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Winnipeg, Manitoba, Canada
Pfizer Investigational Site
Windsor, Ontario, Canada
Pfizer Investigational Site
Saskatoon, Saskatchewan, Canada
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3471018
Identifier Type: -
Identifier Source: org_study_id