Efficacy and Safety of Oral Febuxostat in Participants With Gout
CONFIRMS
A Phase 3, Randomized, Multicenter, Double-Blind, Allopurinol-Controlled Study Assessing the Efficacy and Safety of Oral Febuxostat in Subjects With Gout.
2 other identifiers
interventional
2,269
1 country
258
Brief Summary
The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily (QD), to allopurinol in subjects with hyperuricemia and gout.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2007
Shorter than P25 for phase_3
258 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2007
CompletedFirst Posted
Study publicly available on registry
February 1, 2007
CompletedStudy Start
First participant enrolled
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
July 16, 2009
CompletedFebruary 2, 2012
January 1, 2012
1.1 years
January 25, 2007
March 12, 2009
January 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.
The percentage of subjects whose serum urate level was \<6.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate value was collected.
Last Visit on treatment (up to 6 months)
Secondary Outcomes (16)
Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl
Last Visit on treatment (up to 6 months)
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.
Month 2
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.
Month 4
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit.
Month 6
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit.
Month 2
- +11 more secondary outcomes
Study Arms (3)
Febuxostat 40 mg QD
EXPERIMENTALFebuxostat 80 mg QD
EXPERIMENTALAllopurinol 200 mg or 300 mg QD
ACTIVE COMPARATOR(dependent on renal function)
Interventions
Febuxostat 40 mg, capsules, orally, once daily for up to 6 months.
Allopurinol 200 mg or 300 mg, capsules, orally, once daily for up to 6 months. Dose is dependent on the subject's renal function. Subjects with normal renal function or mild renal impairment received 300 mg once daily; subjects with moderate renal impairment received 200 mg once daily.
Eligibility Criteria
You may qualify if:
- Has one or more of the American Rheumatism Association criteria for the diagnosis of gout.
- Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
- Must have a serum urate level greater than or equal to 8.0 milligram per deciliter (mg/dL).
You may not qualify if:
- Have a severe, unstable, or life threatening medical condition that would likely prevent them from completing this study.
- Has a known body reaction to febuxostat, allopurinol, naproxen, any other non-steroidal anti-inflammatory drug (NSAID), aspirin, lansoprazole, colchicine, or any components in their formulation.
- History of xanthinuria.
- Alcohol consumption greater than 14/week.
- History of significant concomitant illness.
- Active liver or peptic ulcer disease.
- Has rheumatoid arthritis requiring treatment.
- Has estimated creatinine clearance less than 30 milliliter per minute (mL/min) calculated using the Cockcroft-Gault formula corrected for ideal body weight.
- Requires therapy with any other urate-lowering drug other than the study drug; long-term use of NSAIDs and COX-2 inhibitors; salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; intravenous (IV) colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole;trimethoprim.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (258)
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Birmingham, Alabama, United States
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Hoover, Alabama, United States
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Hueytown, Alabama, United States
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Huntsville, Alabama, United States
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Mobile, Alabama, United States
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Montgomery, Alabama, United States
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Northport, Alabama, United States
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Ozark, Alabama, United States
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Tuscaloosa, Alabama, United States
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Chandler, Arizona, United States
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Gilbert, Arizona, United States
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Mesa, Arizona, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Sierra Vista, Arizona, United States
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Tucson, Arizona, United States
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Fort Smith, Arkansas, United States
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Jonesboro, Arkansas, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Carmichael, California, United States
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Clovis, California, United States
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Concord, California, United States
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El Centro, California, United States
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Fair Oaks, California, United States
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Fullerton, California, United States
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Huntington Beach, California, United States
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Irvine, California, United States
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La Jolla, California, United States
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Laguna Hills, California, United States
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Los Angeles, California, United States
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Pasadena, California, United States
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Rancho Cucamonga, California, United States
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Riverside, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Luis Obispo, California, United States
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Santa Barbara, California, United States
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Santa Maria, California, United States
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Torrance, California, United States
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Tustin, California, United States
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Vallejo, California, United States
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Vista, California, United States
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Walnut Creek, California, United States
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West Covina, California, United States
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Westlake Village, California, United States
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Whittier, California, United States
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Boulder, Colorado, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Highlands Ranch, Colorado, United States
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Littleton, Colorado, United States
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Longmont, Colorado, United States
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Wheat Ridge, Colorado, United States
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Danbury, Connecticut, United States
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Trumbull, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Aventura, Florida, United States
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Boynton Beach, Florida, United States
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Brandon, Florida, United States
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Daytona Beach, Florida, United States
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DeLand, Florida, United States
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Delray Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Fort Myers, Florida, United States
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Gainsville, Florida, United States
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Hallandale, Florida, United States
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Hialeah, Florida, United States
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Holly Hill, Florida, United States
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Jupiter, Florida, United States
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Kissimmee, Florida, United States
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Largo, Florida, United States
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Miami, Florida, United States
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Naples, Florida, United States
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New Port Richey, Florida, United States
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New Smyrna Beach, Florida, United States
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Opa-locka, Florida, United States
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Orlando, Florida, United States
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South Miami, Florida, United States
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St. Petersburg, Florida, United States
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Tallahassee, 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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Winter Haven, Florida, United States
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Zephyrhills, Florida, United States
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Atlanta, Georgia, United States
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Conyers, Georgia, United States
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Decatur, Georgia, United States
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Dunwoody, Georgia, United States
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Gainesville, Georgia, United States
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Marietta, Georgia, United States
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Stockbridge, Georgia, United States
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Honolulu, Hawaii, United States
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Boise, Idaho, United States
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Coeur d'Alene, Idaho, United States
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Meridian, Idaho, United States
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Nampa, Idaho, United States
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Arlington Heights, Illinois, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Springfield, Illinois, United States
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Vernon Hills, Illinois, United States
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Elkhart, Indiana, United States
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Evansville, Indiana, United States
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Mishawaka, Indiana, United States
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Clive, Iowa, United States
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Des Moines, Iowa, United States
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Dubuque, Iowa, United States
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Kansas City, Kansas, United States
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Wichita, Kansas, United States
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Elizabethtown, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Ruston, Louisiana, United States
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Shreveport, Louisiana, United States
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Slidell, Louisiana, United States
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Baltimore, Maryland, United States
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Frederick, Maryland, United States
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Owings Mills, Maryland, United States
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Prince Frederick, Maryland, United States
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Wheaton, Maryland, United States
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Fall River, Massachusetts, United States
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New Bedford, Massachusetts, United States
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Springfield, Massachusetts, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Flint, Michigan, United States
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Kalamazoo, Michigan, United States
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Lansing, Michigan, United States
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Stevensville, Michigan, United States
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Troy, Michigan, United States
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Chaska, Minnesota, United States
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Flowood, Mississippi, United States
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Jackson, Mississippi, United States
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Olive Branch, Mississippi, United States
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Florissant, Missouri, United States
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Jefferson City, Missouri, United States
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Manchester, Missouri, United States
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Mexico, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Butte, Montana, United States
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Grand Island, Nebraska, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Dover, New Hampshire, United States
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Blackwood, New Jersey, United States
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Edison, New Jersey, United States
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Flemington, New Jersey, United States
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Manalapan, New Jersey, United States
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Medford, New Jersey, United States
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Midland Park, New Jersey, United States
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Albuquerque, New Mexico, United States
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Endwell, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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Smithtown, New York, United States
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Syracuse, New York, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Greenville, North Carolina, United States
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Harrisburg, North Carolina, United States
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High Point, North Carolina, United States
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Lenoir, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Austintown, Ohio, United States
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Beachwood, Ohio, United States
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Chardon, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
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Hudson, Ohio, United States
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Kettering, Ohio, United States
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Lyndhurst, Ohio, United States
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Perrysburg, Ohio, United States
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Toledo, Ohio, United States
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Willoughby Hills, Ohio, United States
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Youngstown, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Bend, Oregon, United States
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Eugene, Oregon, United States
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Lake Oswego, Oregon, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Bethlehem, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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East Norriton, Pennsylvania, United States
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Feasterville-Trevose, Pennsylvania, United States
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Harrisburg, Pennsylvania, United States
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Lansdale, Pennsylvania, United States
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Mechanicsburg, Pennsylvania, United States
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Morrisville, Pennsylvania, United States
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Penndel, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Reading, Pennsylvania, United States
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Scotland, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Cranston, Rhode Island, United States
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East Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Greenville, 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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Orangeburg, South Carolina, United States
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Simpsonville, South Carolina, United States
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Spartanburg, South Carolina, United States
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Bristol, Tennessee, United States
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Chattanooga, Tennessee, United States
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Clarksville, Tennessee, United States
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Collierville, Tennessee, United States
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Jackson, Tennessee, United States
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Johnson City, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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New Tazewell, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Bellaire, Texas, United States
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Bryan, Texas, 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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Houston, Texas, United States
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Killeen, Texas, United States
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Lake Jackson, Texas, United States
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Odessa, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Waco, Texas, United States
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Layton, Utah, United States
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Midvale, Utah, United States
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Salt Lake City, Utah, United States
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St. George, Utah, United States
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West Jordan, Utah, United States
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Chesapeake, Virginia, United States
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Newport News, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Everett, Washington, United States
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Gig Harbor, Washington, United States
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Lakewood, Washington, United States
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Olympia, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Vancouver, Washington, United States
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Monroe, Wisconsin, United States
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Oregon, Wisconsin, United States
Related Publications (7)
Becker MA, Schumacher HR, Espinoza LR, Wells AF, MacDonald P, Lloyd E, Lademacher C. The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. Arthritis Res Ther. 2010;12(2):R63. doi: 10.1186/ar2978. Epub 2010 Apr 6.
PMID: 20370912RESULTWortmann RL, Macdonald PA, Hunt B, Jackson RL. Effect of prophylaxis on gout flares after the initiation of urate-lowering therapy: analysis of data from three phase III trials. Clin Ther. 2010 Dec;32(14):2386-97. doi: 10.1016/j.clinthera.2011.01.008.
PMID: 21353107RESULTBecker MA, MacDonald PA, Hunt B, Gunawardhana L. Treating hyperuricemia of gout: safety and efficacy of febuxostat and allopurinol in older versus younger subjects. Nucleosides Nucleotides Nucleic Acids. 2011 Dec;30(12):1011-7. doi: 10.1080/15257770.2011.603715.
PMID: 22132950RESULTChohan S, Becker MA, MacDonald PA, Chefo S, Jackson RL. Women with gout: efficacy and safety of urate-lowering with febuxostat and allopurinol. Arthritis Care Res (Hoboken). 2012 Feb;64(2):256-61. doi: 10.1002/acr.20680.
PMID: 22052584RESULTBecker MA, MacDonald PA, Hunt BJ, Jackson RL. Diabetes and gout: efficacy and safety of febuxostat and allopurinol. Diabetes Obes Metab. 2013 Nov;15(11):1049-55. doi: 10.1111/dom.12135. Epub 2013 Jun 12.
PMID: 23683134DERIVEDJackson RL, Hunt B, MacDonald PA. The efficacy and safety of febuxostat for urate lowering in gout patients >/=65 years of age. BMC Geriatr. 2012 Mar 21;12:11. doi: 10.1186/1471-2318-12-11.
PMID: 22436129DERIVEDWells AF, MacDonald PA, Chefo S, Jackson RL. African American patients with gout: efficacy and safety of febuxostat vs allopurinol. BMC Musculoskelet Disord. 2012 Feb 9;13:15. doi: 10.1186/1471-2474-13-15.
PMID: 22316106DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. VP, Clinical Sciences
- Organization
- Takeda Global Research and Development Center, Inc.
Study Officials
- STUDY CHAIR
Medical Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2007
First Posted
February 1, 2007
Study Start
February 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
February 2, 2012
Results First Posted
July 16, 2009
Record last verified: 2012-01