Back to resultsFebuxostat Versus Allopurinol Control Trial in Subjects With Gout (FACT)
Primary Purpose
Gout
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Febuxostat
Febuxostat
Allopurinol
Sponsored by
About this trial
This is an interventional treatment trial for Gout focused on measuring uric Acid, xanthine oxidase, tophi, Drug Therapy
Eligibility Criteria
Inclusion Criteria: Meeting the preliminary criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout. Serum uric acid ≥ 8.0 milligrams per deciliter (mg/dL) at Baseline Exclusion Criteria: Serum creatinine >1.5 mg/dL Calculated creatinine clearance of <50 milliliters per minutes (mL/min) Pregnancy or lactation; Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (>325 mg) or other salicylates; Body Mass Index (BMI) >50 kilogram per meter²(kg/m²); A history of xanthinuria, active liver disease, or hepatic dysfunction; A history of alcohol abuse or intake of 14 or more alcohol-containing drinks/week.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Febuxostat 80 mg QD
Febuxostat 120 mg QD
Allopurinol 300 mg QD
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)
Each subject's serum urate at the last 3 visits determined the subject's response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.
Secondary Outcome Measures
Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit
Serum urate values were obtained at the Week 28 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 28 visit was summarized.
Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit
Serum urate values were obtained at the Week 52 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 52 visit was summarized.
Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit
The percentage of subjects 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. The timing of the final visit may have differed for each subject.
Percent Change From Baseline in Serum Urate Levels at Week 28.
Serum urate values were obtained at the Week 28 visit. The percent change in serum urate was calculated as [(week 28 - baseline levels/baseline)]*100 and summarized.
Percent Change From Baseline in Serum Urate Levels at Week 52.
Serum urate values were obtained at the Week 52 visit. The percent change in serum urate was calculated as [(week 52 - baseline levels/baseline)]*100 and summarized.
Percent Change From Baseline in Serum Urate Levels at Final Visit
The percent change in serum urate from baseline to the Final visit was calculated as [(Final Visit - baseline levels/baseline)]*100 and summarized. The Final visit was the last visit with a serum urate value. The timing of the final visit may have differed for each subject.
Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 28 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 28 visit, the size was assumed to be zero.
Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 52 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 52 visit, the size was assumed to be zero.
Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
Percent change in primary tophus size was calculated as [(Final Visit - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at Screening. If tophus was not palpable at Final visit, the size was assumed to be 0. The timing of the final visit may have differed for each subject.
Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening.
The change from baseline at Week 28 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were no longer palpable at the Week 28 visit, the total count was assumed to be zero.
Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening.
The change from baseline at Week 52 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were no longer palpable at the Week 52 visit, the total count was assumed to be zero.
Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening.
Change in number of tophi/subject calculated for the subset of subjects with palpable tophi at Screening. If the tophi were not palpable at the Final Visit, total count was assumed to be 0. The timing of the final visit may have differed for each subject.
Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52.
The percentage of subjects requiring treatment for a gout flare between Weeks 8 and 52 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00102440
Brief Title
Febuxostat Versus Allopurinol Control Trial in Subjects With Gout
Acronym
FACT
Official Title
A Phase 3, Randomized, Multicenter Study Comparing the Safety and Efficacy of Oral Febuxostat Versus Allopurinol in Subjects With Gout
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout.
Detailed Description
This was a randomized, controlled, double-blind study of 52 weeks duration. Subjects receiving prior urate-lowering therapy underwent a 2-week washout period prior to randomization. Subjects were then randomized to one of three treatment groups: febuxostat 80 milligram (mg), febuxostat 120 mg, or allopurinol 300 mg. Naproxen (250 mg twice daily) or colchicine (0.6 mg once daily) was provided for prophylaxis of acute gout flares during the washout period and the first 8 weeks of double-blind treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout
Keywords
uric Acid, xanthine oxidase, tophi, Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
760 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Febuxostat 80 mg QD
Arm Type
Experimental
Arm Title
Febuxostat 120 mg QD
Arm Type
Experimental
Arm Title
Allopurinol 300 mg QD
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Febuxostat
Other Intervention Name(s)
TMX-67, Tei-6720, Uloric
Intervention Description
Febuxostat 80 mg, orally, once daily for up to 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Febuxostat
Other Intervention Name(s)
TMX-67, Tei-6720, Uloric
Intervention Description
Febuxostat 120 mg, orally, once daily for up to 52 weeks.
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Intervention Description
Allopurinol 300 mg, capsules, orally, once daily for up to 52 weeks.
Primary Outcome Measure Information:
Title
Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)
Description
Each subject's serum urate at the last 3 visits determined the subject's response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject.
Time Frame
Last 3 Visits (up to 52 weeks)
Secondary Outcome Measure Information:
Title
Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit
Description
Serum urate values were obtained at the Week 28 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 28 visit was summarized.
Time Frame
Week 28
Title
Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit
Description
Serum urate values were obtained at the Week 52 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 52 visit was summarized.
Time Frame
Week 52
Title
Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit
Description
The percentage of subjects 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. The timing of the final visit may have differed for each subject.
Time Frame
Final Visit (up to 52 weeks)
Title
Percent Change From Baseline in Serum Urate Levels at Week 28.
Description
Serum urate values were obtained at the Week 28 visit. The percent change in serum urate was calculated as [(week 28 - baseline levels/baseline)]*100 and summarized.
Time Frame
Baseline and Week 28
Title
Percent Change From Baseline in Serum Urate Levels at Week 52.
Description
Serum urate values were obtained at the Week 52 visit. The percent change in serum urate was calculated as [(week 52 - baseline levels/baseline)]*100 and summarized.
Time Frame
Baseline and Week 52
Title
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 calculated as [(Final Visit - baseline levels/baseline)]*100 and summarized. The Final visit was the last visit with a serum urate value. The timing of the final visit may have differed for each subject.
Time Frame
Baseline and Final Visit (up to 52 weeks)
Title
Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
Description
The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 28 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 28 visit, the size was assumed to be zero.
Time Frame
Baseline and Week 28
Title
Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
Description
The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 52 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 52 visit, the size was assumed to be zero.
Time Frame
Baseline and Week 52
Title
Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
Description
Percent change in primary tophus size was calculated as [(Final Visit - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at Screening. If tophus was not palpable at Final visit, the size was assumed to be 0. The timing of the final visit may have differed for each subject.
Time Frame
Baseline and Final Visit (up to 52 weeks)
Title
Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening.
Description
The change from baseline at Week 28 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were no longer palpable at the Week 28 visit, the total count was assumed to be zero.
Time Frame
Baseline and Week 28
Title
Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening.
Description
The change from baseline at Week 52 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were no longer palpable at the Week 52 visit, the total count was assumed to be zero.
Time Frame
Baseline and Week 52
Title
Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening.
Description
Change in number of tophi/subject calculated for the subset of subjects with palpable tophi at Screening. If the tophi were not palpable at the Final Visit, total count was assumed to be 0. The timing of the final visit may have differed for each subject.
Time Frame
Baseline and Final Visit (up to 52 weeks)
Title
Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52.
Description
The percentage of subjects requiring treatment for a gout flare between Weeks 8 and 52 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once.
Time Frame
Weeks 8 through 52
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:
Meeting the preliminary criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout.
Serum uric acid ≥ 8.0 milligrams per deciliter (mg/dL) at Baseline
Exclusion Criteria:
Serum creatinine >1.5 mg/dL
Calculated creatinine clearance of <50 milliliters per minutes (mL/min)
Pregnancy or lactation;
Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (>325 mg) or other salicylates;
Body Mass Index (BMI) >50 kilogram per meter²(kg/m²);
A history of xanthinuria, active liver disease, or hepatic dysfunction;
A history of alcohol abuse or intake of 14 or more alcohol-containing drinks/week.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Takeda
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
16339094
Citation
Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Eustace D, Palo WA, Streit J, Joseph-Ridge N. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med. 2005 Dec 8;353(23):2450-61. doi: 10.1056/NEJMoa050373.
Results Reference
result
PubMed Identifier
18600509
Citation
Becker MA, MacDonald PA, Hunt BJ, Lademacher C, Joseph-Ridge N. Determinants of the clinical outcomes of gout during the first year of urate-lowering therapy. Nucleosides Nucleotides Nucleic Acids. 2008 Jun;27(6):585-91. doi: 10.1080/15257770802136032.
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
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
Links:
URL
http://www.rheumatology.org/
Description
American College of Rheumatology
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
Febuxostat Versus Allopurinol Control Trial in Subjects With Gout
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