Back to resultsEfficacy and Safety of Oral Febuxostat in Participants With Gout (CONFIRMS)
Primary Purpose
Gout
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Febuxostat
Febuxostat
Allopurinol
Sponsored by
About this trial
This is an interventional treatment trial for Gout focused on measuring tophi, hyperuricemia, uric acid, Drug Therapy
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Febuxostat 40 mg QD
Febuxostat 80 mg QD
Allopurinol 200 mg or 300 mg QD
Arm Description
(dependent on renal function)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl
The percentage of subjects with mild-to-moderate renal impairment whose serum urate 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.
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.
Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 2 visit was summarized.
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.
Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 4 visit was summarized.
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit.
Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 6 visit was summarized.
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit.
Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 2 visit was summarized.
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit.
Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 4 visit was summarized.
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit.
Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 6 visit was summarized.
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit.
The percentage of subjects whose serum urate level was <5.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit
Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 2 visit was summarized.
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit
Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 4 visit was summarized.
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit
Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 6 visit was summarized.
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit
The percentage of subjects whose serum urate level was <4.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.
Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit.
Serum urate values were obtained at the Month 2 visit. The percent change in serum urate from baseline to the Month 2 visit was summarized.
Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit
Serum urate values were obtained at the Month 4 visit. The percent change in serum urate from baseline to the Month 4 visit was summarized.
Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit.
Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.
Mean Percent Change From Baseline in Serum Urate Levels at Final Visit.
The percent change in serum urate from baseline to the Final visit was summarized. The final visit was the last visit at which a serum urate value was collected.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00430248
Brief Title
Efficacy and Safety of Oral Febuxostat in Participants With Gout
Acronym
CONFIRMS
Official Title
A Phase 3, Randomized, Multicenter, Double-Blind, Allopurinol-Controlled Study Assessing the Efficacy and Safety of Oral Febuxostat in Subjects With Gout.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Renal impairment is common in subjects with gout, with the prevalence ranging from 50% to 70%. This population represents an unmet medical need as uricosuric drugs are contraindicated in these patients, and the only available treatment, allopurinol, may have to be dose reduced to avoid overt side effects.
Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.
Treatment duration will be 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout
Keywords
tophi, hyperuricemia, uric acid, Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2269 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Febuxostat 40 mg QD
Arm Type
Experimental
Arm Title
Febuxostat 80 mg QD
Arm Type
Experimental
Arm Title
Allopurinol 200 mg or 300 mg QD
Arm Type
Active Comparator
Arm Description
(dependent on renal function)
Intervention Type
Drug
Intervention Name(s)
Febuxostat
Other Intervention Name(s)
TMX-67, Tei-6720, Uloric
Intervention Description
Febuxostat 40 mg, capsules, orally, once daily for up to 6 months.
Intervention Type
Drug
Intervention Name(s)
Febuxostat
Other Intervention Name(s)
TMX-67, Tei-6720, Uloric
Intervention Description
Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Other Intervention Name(s)
Zyloprim
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.
Description
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.
Time Frame
Last Visit on treatment (up to 6 months)
Secondary Outcome Measure Information:
Title
Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl
Description
The percentage of subjects with mild-to-moderate renal impairment whose serum urate 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.
Time Frame
Last Visit on treatment (up to 6 months)
Title
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.
Description
Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 2 visit was summarized.
Time Frame
Month 2
Title
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.
Description
Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 4 visit was summarized.
Time Frame
Month 4
Title
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit.
Description
Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 6 visit was summarized.
Time Frame
Month 6
Title
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit.
Description
Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 2 visit was summarized.
Time Frame
Month 2
Title
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit.
Description
Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 4 visit was summarized.
Time Frame
Month 4
Title
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit.
Description
Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <5.0 mg/dL at the Month 6 visit was summarized.
Time Frame
Month 6
Title
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit.
Description
The percentage of subjects whose serum urate level was <5.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.
Time Frame
Last Visit on treatment (up to 6 months)
Title
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit
Description
Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 2 visit was summarized.
Time Frame
Month 2
Title
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit
Description
Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 4 visit was summarized.
Time Frame
Month 4
Title
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit
Description
Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <4.0 mg/dL at the Month 6 visit was summarized.
Time Frame
Month 6
Title
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit
Description
The percentage of subjects whose serum urate level was <4.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.
Time Frame
Last Visit on treatment (up to 6 months)
Title
Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit.
Description
Serum urate values were obtained at the Month 2 visit. The percent change in serum urate from baseline to the Month 2 visit was summarized.
Time Frame
Baseline and Month 2
Title
Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit
Description
Serum urate values were obtained at the Month 4 visit. The percent change in serum urate from baseline to the Month 4 visit was summarized.
Time Frame
Baseline and Month 4
Title
Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit.
Description
Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.
Time Frame
Baseline and Month 6
Title
Mean Percent Change From Baseline in Serum Urate Levels at Final Visit.
Description
The percent change in serum urate from baseline to the Final visit was summarized. The final visit was the last visit at which a serum urate value was collected.
Time Frame
Baseline and Last Visit on treatment (up to 6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Takeda
Official's Role
Study Chair
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Hoover
State/Province
Alabama
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United States
City
Hueytown
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Alabama
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United States
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Huntsville
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Alabama
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United States
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Mobile
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Alabama
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Montgomery
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Alabama
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Northport
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Alabama
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Ozark
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Tuscaloosa
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Chandler
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Arizona
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Gilbert
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Mesa
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Peoria
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Phoenix
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Scottsdale
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Sierra Vista
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Tucson
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Fort Smith
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Arkansas
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Jonesboro
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Arkansas
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Little Rock
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Arkansas
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Anaheim
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California
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Carmichael
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Clovis
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Concord
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El Centro
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Fair Oaks
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Fullerton
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United States
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Huntington Beach
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Irvine
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California
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Laguna Hills
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LaJolla
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Los Angeles
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Pasadena
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Rancho Cucamonga
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Riverside
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Sacramento
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San Diego
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San Luis Obispo
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Santa Barbara
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Santa Maria
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Torrance
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Tustin
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California
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Vallejo
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California
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United States
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Vista
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California
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Walnut Creek
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California
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West Covina
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California
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United States
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Westlake Village
State/Province
California
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United States
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Whittier
State/Province
California
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United States
City
Boulder
State/Province
Colorado
Country
United States
City
Colorado Springs
State/Province
Colorado
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Highlands Ranch
State/Province
Colorado
Country
United States
City
Littleton
State/Province
Colorado
Country
United States
City
Longmont
State/Province
Colorado
Country
United States
City
Wheat Ridge
State/Province
Colorado
Country
United States
City
Danbury
State/Province
Connecticut
Country
United States
City
Trumbull
State/Province
Connecticut
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United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Aventura
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Florida
Country
United States
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Boynton Beach
State/Province
Florida
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United States
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Brandon
State/Province
Florida
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United States
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Daytona Beach
State/Province
Florida
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United States
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DeLand
State/Province
Florida
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Delray Beach
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Florida
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Fort Lauderdale
State/Province
Florida
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Fort Myers
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Florida
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Gainsville
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Florida
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Hallandale
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Florida
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Hialeah
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Florida
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United States
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Holly Hill
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Florida
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Jupiter
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Florida
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Kissimmee
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Florida
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Largo
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Florida
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United States
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Miami
State/Province
Florida
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United States
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Naples
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Florida
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New Port Richey
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Florida
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New Smyrna Beach
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Florida
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Opa Locka
State/Province
Florida
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Orlando
State/Province
Florida
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South Miami
State/Province
Florida
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St. Petersburg
State/Province
Florida
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United States
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Tallahassee
State/Province
Florida
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United States
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Tampa
State/Province
Florida
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West Palm Beach
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Florida
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Winter Haven
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Florida
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United States
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Zephyrhills
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Florida
Country
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Atlanta
State/Province
Georgia
Country
United States
City
Conyers
State/Province
Georgia
Country
United States
City
Decatur
State/Province
Georgia
Country
United States
City
Dunwoody
State/Province
Georgia
Country
United States
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Gainesville
State/Province
Georgia
Country
United States
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Marietta
State/Province
Georgia
Country
United States
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Stockbridge
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Georgia
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United States
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Honolulu
State/Province
Hawaii
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United States
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Boise
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Idaho
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United States
City
Coeur d'Alene
State/Province
Idaho
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United States
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Meridian
State/Province
Idaho
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United States
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Nampa
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Idaho
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United States
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Arlington Heights
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Illinois
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United States
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Chicago
State/Province
Illinois
Country
United States
City
Evanston
State/Province
Illinois
Country
United States
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Springfield
State/Province
Illinois
Country
United States
City
Vernon Hills
State/Province
Illinois
Country
United States
City
Elkhart
State/Province
Indiana
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
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Mishawaka
State/Province
Indiana
Country
United States
City
Clive
State/Province
Iowa
Country
United States
City
Des Moines
State/Province
Iowa
Country
United States
City
Dubuque
State/Province
Iowa
Country
United States
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Kansas City
State/Province
Kansas
Country
United States
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Wichita
State/Province
Kansas
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United States
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Elizabethtown
State/Province
Kentucky
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
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Louisville
State/Province
Kentucky
Country
United States
City
Baton Rouge
State/Province
Louisiana
Country
United States
City
Metairie
State/Province
Louisiana
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Ruston
State/Province
Louisiana
Country
United States
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Shreveport
State/Province
Louisiana
Country
United States
City
Slidell
State/Province
Louisiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Frederick
State/Province
Maryland
Country
United States
City
Owings Mills
State/Province
Maryland
Country
United States
City
Prince Frederick
State/Province
Maryland
Country
United States
City
Wheaton
State/Province
Maryland
Country
United States
City
Fall River
State/Province
Massachusetts
Country
United States
City
New Bedford
State/Province
Massachusetts
Country
United States
City
Springfield
State/Province
Massachusetts
Country
United States
City
Worcester
State/Province
Massachusetts
Country
United States
City
Ann Arbor
State/Province
Michigan
Country
United States
City
Flint
State/Province
Michigan
Country
United States
City
Kalamazoo
State/Province
Michigan
Country
United States
City
Lansing
State/Province
Michigan
Country
United States
City
Stevensville
State/Province
Michigan
Country
United States
City
Troy
State/Province
Michigan
Country
United States
City
Chaska
State/Province
Minnesota
Country
United States
City
Flowood
State/Province
Mississippi
Country
United States
City
Jackson
State/Province
Mississippi
Country
United States
City
Olive Branch
State/Province
Mississippi
Country
United States
City
Florissant
State/Province
Missouri
Country
United States
City
Jefferson City
State/Province
Missouri
Country
United States
City
Manchester
State/Province
Missouri
Country
United States
City
Mexico
State/Province
Missouri
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Billings
State/Province
Montana
Country
United States
City
Butte
State/Province
Montana
Country
United States
City
Grand Island
State/Province
Nebraska
Country
United States
City
Lincoln
State/Province
Nebraska
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Reno
State/Province
Nevada
Country
United States
City
Dover
State/Province
New Hampshire
Country
United States
City
Blackwood
State/Province
New Jersey
Country
United States
City
Edison
State/Province
New Jersey
Country
United States
City
Flemington
State/Province
New Jersey
Country
United States
City
Manalapan
State/Province
New Jersey
Country
United States
City
Medford
State/Province
New Jersey
Country
United States
City
Midland Park
State/Province
New Jersey
Country
United States
City
Albuquerque
State/Province
New Mexico
Country
United States
City
Endwell
State/Province
New York
Country
United States
City
Mineola
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Smithtown
State/Province
New York
Country
United States
City
Syracuse
State/Province
New York
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Greensboro
State/Province
North Carolina
Country
United States
City
Greenville
State/Province
North Carolina
Country
United States
City
Harrisburg
State/Province
North Carolina
Country
United States
City
High Point
State/Province
North Carolina
Country
United States
City
Lenoir
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Austintown
State/Province
Ohio
Country
United States
City
Beachwood
State/Province
Ohio
Country
United States
City
Chardon
State/Province
Ohio
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Dayton
State/Province
Ohio
Country
United States
City
Hudson
State/Province
Ohio
Country
United States
City
Kettering
State/Province
Ohio
Country
United States
City
Lyndhurst
State/Province
Ohio
Country
United States
City
Perrysburg
State/Province
Ohio
Country
United States
City
Toledo
State/Province
Ohio
Country
United States
City
Willoughby Hills
State/Province
Ohio
Country
United States
City
Youngstown
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Tulsa
State/Province
Oklahoma
Country
United States
City
Bend
State/Province
Oregon
Country
United States
City
Eugene
State/Province
Oregon
Country
United States
City
Lake Oswego
State/Province
Oregon
Country
United States
City
Medford
State/Province
Oregon
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Bethlehem
State/Province
Pennsylvania
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
East Norriton
State/Province
Pennsylvania
Country
United States
City
Feasterville Trevose
State/Province
Pennsylvania
Country
United States
City
Harrisburg
State/Province
Pennsylvania
Country
United States
City
Lansdale
State/Province
Pennsylvania
Country
United States
City
Mechanicsburg
State/Province
Pennsylvania
Country
United States
City
Morrisville
State/Province
Pennsylvania
Country
United States
City
Penndel
State/Province
Pennsylvania
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
City
Reading
State/Province
Pennsylvania
Country
United States
City
Scotland
State/Province
Pennsylvania
Country
United States
City
West Reading
State/Province
Pennsylvania
Country
United States
City
Cranston
State/Province
Rhode Island
Country
United States
City
East Providence
State/Province
Rhode Island
Country
United States
City
Charleston
State/Province
South Carolina
Country
United States
City
Columbia
State/Province
South Carolina
Country
United States
City
Greenville
State/Province
South Carolina
Country
United States
City
Greer
State/Province
South Carolina
Country
United States
City
Mount Pleasant
State/Province
South Carolina
Country
United States
City
Orangeburg
State/Province
South Carolina
Country
United States
City
Simpsonville
State/Province
South Carolina
Country
United States
City
Spartanburg
State/Province
South Carolina
Country
United States
City
Bristol
State/Province
Tennessee
Country
United States
City
Chattanooga
State/Province
Tennessee
Country
United States
City
Clarksville
State/Province
Tennessee
Country
United States
City
Collierville
State/Province
Tennessee
Country
United States
City
Jackson
State/Province
Tennessee
Country
United States
City
Johnson City
State/Province
Tennessee
Country
United States
City
Memphis
State/Province
Tennessee
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
New Tazewell
State/Province
Tennessee
Country
United States
City
Amarillo
State/Province
Texas
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Beaumont
State/Province
Texas
Country
United States
City
Bellaire
State/Province
Texas
Country
United States
City
Bryan
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
El Paso
State/Province
Texas
Country
United States
City
Fort Worth
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Killeen
State/Province
Texas
Country
United States
City
Lake Jackson
State/Province
Texas
Country
United States
City
Odessa
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Sugar Land
State/Province
Texas
Country
United States
City
Waco
State/Province
Texas
Country
United States
City
Layton
State/Province
Utah
Country
United States
City
Midvale
State/Province
Utah
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
St. George
State/Province
Utah
Country
United States
City
West Jordan
State/Province
Utah
Country
United States
City
Chesapeake
State/Province
Virginia
Country
United States
City
Newport News
State/Province
Virginia
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Richmond
State/Province
Virginia
Country
United States
City
Everett
State/Province
Washington
Country
United States
City
Gig Harbor
State/Province
Washington
Country
United States
City
Lakewood
State/Province
Washington
Country
United States
City
Olympia
State/Province
Washington
Country
United States
City
Spokane
State/Province
Washington
Country
United States
City
Tacoma
State/Province
Washington
Country
United States
City
Vancouver
State/Province
Washington
Country
United States
City
Monroe
State/Province
Wisconsin
Country
United States
City
Oregon
State/Province
Wisconsin
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20370912
Citation
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.
Results Reference
result
PubMed Identifier
21353107
Citation
Wortmann 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.
Results Reference
result
PubMed Identifier
22132950
Citation
Becker 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.
Results Reference
result
PubMed Identifier
22052584
Citation
Chohan 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.
Results Reference
result
PubMed Identifier
23683134
Citation
Becker 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.
Results Reference
derived
PubMed Identifier
22436129
Citation
Jackson 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.
Results Reference
derived
PubMed Identifier
22316106
Citation
Wells 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.
Results Reference
derived
Links:
URL
http://general.takedapharm.com/content/file.aspx?applicationcode=6C7C39D8-5D09-453B-BF30-696A4AB88E62&fileTypeCode=ULORICPI
Description
Uloric Package Insert
Learn more about this trial
Efficacy and Safety of Oral Febuxostat in Participants With Gout
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