Clinical trial NCT00102440: Febuxostat Versus Allopurinol Control Trial in Subjects With Gout
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gout
Keywords: uric Acid
xanthine oxidase
tophi
Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-01-31
Enrollment: 760
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)
timeFrame: Last 3 Visits (up to 52 weeks)
Secondary outcomes:
measure: Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit
timeFrame: Week 28
measure: Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit
timeFrame: Week 52
measure: Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit
timeFrame: Final Visit (up to 52 weeks)
measure: Percent Change From Baseline in Serum Urate Levels at Week 28.
timeFrame: Baseline and Week 28
measure: Percent Change From Baseline in Serum Urate Levels at Week 52.
timeFrame: Baseline and Week 52
measure: Percent Change From Baseline in Serum Urate Levels at Final Visit
timeFrame: Baseline and Final Visit (up to 52 weeks)
measure: Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
timeFrame: Baseline and Week 28
measure: Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
timeFrame: Baseline and Week 52
measure: Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.
timeFrame: Baseline and Final Visit (up to 52 weeks)
measure: Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening.
timeFrame: Baseline and Week 28
measure: Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening.
timeFrame: Baseline and Week 52
measure: Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening.
timeFrame: Baseline and Final Visit (up to 52 weeks)
measure: Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52.
timeFrame: Weeks 8 through 52
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.