Phase 3 N=760 Randomized Triple-blind Treatment

Febuxostat Versus Allopurinol Control Trial in Subjects With Gout

Gout

Bottom Line

View on ClinicalTrials.gov: NCT00102440 ↗

Enrolled (actual)

760

Serious AEs

6.2%

Results posted

Jul 2009

Primary outcome: Primary: Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL) — 53; 62; 21 Percentage of subjects — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Febuxostat (Drug); Allopurinol (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Takeda
Primary completion: Feb 2004

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL)	53; 62; 21	<0.001 sig
SECONDARY Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit	72; 82; 42	<0.001 sig
SECONDARY Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit	81; 82; 39	<0.001 sig
SECONDARY Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit	74; 80; 36	<0.001 sig
SECONDARY Percent Change From Baseline in Serum Urate Levels at Week 28.	-46.3; -53.5; -34.8	<0.001 sig
SECONDARY Percent Change From Baseline in Serum Urate Levels at Week 52.	-47.7; -53.0; -34.8	<0.001 sig
SECONDARY Percent Change From Baseline in Serum Urate Levels at Final Visit	-44.7; -51.5; -33.0	<0.001 sig
SECONDARY Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.	-29.5; -49.5; -28.6	>0.999
SECONDARY Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.	-83.4; -65.5; -49.7	0.083
SECONDARY Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening.	-51.7; -43.8; -39.6	0.080
SECONDARY Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening.	0.0; 0.0; 0.0	0.674
SECONDARY Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening.	0.0; -1.0; 0.0	0.507
SECONDARY Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening.	0.0; 0.0; 0.0	0.657
SECONDARY Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52.	64; 70; 64	>0.999

Summary

The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout.

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00102440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.