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

Phase 3

Completed

• Conditions: Gout
• Interventions: Drug: Placebo; Drug: Febuxostat; Drug: Allopurinol

• Registration Number: NCT00174915
• Lead Sponsor: Takeda

Brief Summary

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

Detailed Description

A Phase 3 Study comparing 80 mg, 120 mg or 240 mg of febuxostat, allopurinol (300 mg for those with normal renal function and 100 mg for those with impaired renal function) and placebo administered once daily in subjects with gout.

Subjects will receive treatment for 28 weeks.

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Results First Submitted: 2009-03-12
• Results First Submitted QC: 2009-05-26
• Results First Posted: 2009-07-16
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-31
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1072

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 < 2.0 mg/dL and creatinine clearance 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo QD	Placebo	-
Febuxostat 80 mg QD	Febuxostat	-
Febuxostat 120 mg QD	Febuxostat	-
Febuxostat 240 mg QD	Febuxostat	-
Allopurinol QD	Allopurinol	-

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Whose Last Three Serum Urate Levels Are <6.0 Milligram Per Deciliter (mg/dL).	Last 3 visits (any last 3 visits up to week 28)	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

Name	Time	Method
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Week 28	Week 28	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 Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit	Final Visit (up to 28 weeks).	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 and may have differed by subject.
Percent Change From Baseline in Serum Urate Levels at Week 28.	Baseline and 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 Final Visit	Baseline and Final Visit (up to 28 weeks)	The percent change in serum urate from baseline to the Final visit was summarized. The percent change in serum urate was calculated as \[(Final visit - baseline levels)/baseline\]\*100. 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 in Primary Tophus Size at Week 28, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.	Baseline and Week 28	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 in Primary Tophus Size at Final Visit, as Determined by Physical Measurement in the Subset of Subjects With Palpable Tophi at the Screening Visit.	Baseline and Final Visit (up to 28 weeks)	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 in the Total Number of Tophi at Week 28 in the Subset of Subjects With Palpable Tophi at the Screening Visit.	Baseline and Week 28	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 not palpable at the Week 28 visit, the total count was assumed to be 0.
Change in the Total Number of Tophi at Final Visit in the Subset of Subjects With Palpable Tophi at the Screening Visit	Final Visit (up to 28 weeks)	Change in number of tophi/subject was calculated for the subset of subjects with palpable tophi at the 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 a Gout Flare Between Weeks 8 and 28 of the Double-Blind Treatment Period.	Weeks 8 through 28	Percentage of subjects requiring treatment for a gout flare between Weeks 8 and 28 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once.