Phase 3 N=1,072 Randomized Triple-blind Treatment

Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.

Gout

Bottom Line

View on ClinicalTrials.gov: NCT00174915 ↗

Enrolled (actual)

1,072

Serious AEs

3.2%

Results posted

Jul 2009

Primary outcome: Primary: Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL). — 48; 65; 69; 22 Percentage of subjects — p=<0.001

Study Design & Population

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL).	48; 65; 69; 22; 0	<0.001 sig
SECONDARY Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28	76; 87; 94; 41; 1	<0.001 sig
SECONDARY Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit	72; 79; 92; 39; 1	<0.001 sig
SECONDARY Percent Change From Baseline in Serum Urate Levels at Week 28.	-47.6; -54.9; -67.8; -34.4; -3.6	<0.001 sig
SECONDARY Percent Change From Baseline in Serum Urate Levels at Final Visit	-45.2; -51.9; -66.3; -33.7; -3.0	<0.001 sig
SECONDARY Percent Change in Primary Tophus Size at Week 28, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.	-45.6; -54.2; -53.2; -31.5; -52.0	0.789
SECONDARY Percent Change in Primary Tophus Size at Final Visit, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.	-33.8; -42.4; -47.0; -22.6; -40.3	0.699
SECONDARY Change in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit.	0.0; 0.0; 0.0; 0.0; 0.0	0.949
SECONDARY Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit	0.0; 0.0; 0.0; 0.0; 0.0	0.683
SECONDARY Percentage of Subjects Requiring Treatment for a Gout Flare Between Weeks 8 and 28 of the Double-Blind Treatment Period.	55; 54; 57; 46; 52	0.645

Summary

The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout.

Eligibility Criteria

Inclusion Criteria

Hyperuricemia (serum urate ≥8.0 mg/dL and gout by American Rheumatism Association Criteria
Renal function defined as a serum creatinine level of 20 milliliters per minute (mL/min) by Cockroft and Gault formula.

Exclusion Criteria

History of xanthinuria
Intolerance to allopurinol
Presence of renal calculi,
Alcohol intake of ≥ 14 drinks/week
Clinically significant medical condition

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00174915). 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.