Efficacy and Safety of Oral Febuxostat in Participants With Gout

Phase 3

Completed

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

• Registration Number: NCT00430248
• Lead Sponsor: Takeda

Brief Summary

The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily (QD), to allopurinol in subjects with hyperuricemia and gout.

Detailed Description

Renal impairment is common in subjects with gout, with the prevalence ranging from 50% to 70%. This population represents an unmet medical need as uricosuric drugs are contraindicated in these patients, and the only available treatment, allopurinol, may have to be dose reduced to avoid overt side effects.

Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.

Treatment duration will be 6 months.

Study Timeline

• Study First Submitted: 2007-01-25
• Study First Submitted QC: 2007-01-31
• Study Start: 2007-02
• Study First Posted: 2007-02-01
• Primary Completion: 2008-03
• Study Completion: 2008-03
• 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: 2269

Inclusion Criteria

• Has one or more of the American Rheumatism Association criteria for the diagnosis of gout.
• Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
• Must have a serum urate level greater than or equal to 8.0 milligram per deciliter (mg/dL).

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Exclusion Criteria

• Have a severe, unstable, or life threatening medical condition that would likely prevent them from completing this study.
• Has a known body reaction to febuxostat, allopurinol, naproxen, any other non-steroidal anti-inflammatory drug (NSAID), aspirin, lansoprazole, colchicine, or any components in their formulation.
• History of xanthinuria.
• Alcohol consumption greater than 14/week.
• History of significant concomitant illness.
• Active liver or peptic ulcer disease.
• Has rheumatoid arthritis requiring treatment.
• Has estimated creatinine clearance less than 30 milliliter per minute (mL/min) calculated using the Cockcroft-Gault formula corrected for ideal body weight.
• Requires therapy with any other urate-lowering drug other than the study drug; long-term use of NSAIDs and COX-2 inhibitors; salicylates; thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; intravenous (IV) colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole;trimethoprim.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Febuxostat 40 mg QD	Febuxostat	-
Febuxostat 80 mg QD	Febuxostat	-
Allopurinol 200 mg or 300 mg QD	Allopurinol	(dependent on renal function)

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Whose Serum Urate Level is <6.0 Milligrams Per Deciliter (mg/dL) at the Final Visit.	Last Visit on treatment (up to 6 months)	The percentage of subjects whose serum urate level 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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Renal Impairment Subjects Whose Final Visit Serum Urate Level is <6.0 mg/dl	Last Visit on treatment (up to 6 months)	The percentage of subjects with mild-to-moderate renal impairment 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.
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 2 Visit.	Month 2	Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 2 visit was summarized.
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 4 Visit.	Month 4	Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 4 visit was summarized.
Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Month 6 Visit.	Month 6	Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was \<6.0 mg/dL at the Month 6 visit was summarized.
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 2 Visit.	Month 2	Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was \<5.0 mg/dL at the Month 2 visit was summarized.
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 4 Visit.	Month 4	Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was \<5.0 mg/dL at the Month 4 visit was summarized.
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Month 6 Visit.	Month 6	Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was \<5.0 mg/dL at the Month 6 visit was summarized.
Percentage of Subjects Whose Serum Urate Levels Are <5.0 mg/dL at Final Visit.	Last Visit on treatment (up to 6 months)	The percentage of subjects whose serum urate level was \<5.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 2 Visit	Month 2	Serum urate values were obtained at the Month 2 visit. The percentage of subjects whose serum urate was \<4.0 mg/dL at the Month 2 visit was summarized.
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 4 Visit	Month 4	Serum urate values were obtained at the Month 4 visit. The percentage of subjects whose serum urate was \<4.0 mg/dL at the Month 4 visit was summarized.
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Month 6 Visit	Month 6	Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was \<4.0 mg/dL at the Month 6 visit was summarized.
Percentage of Subjects Whose Serum Urate Levels Are <4.0 mg/dL at Final Visit	Last Visit on treatment (up to 6 months)	The percentage of subjects whose serum urate level was \<4.0 mg/dL at the Final Visit was summarized. The Final Visit was the last visit at which a serum urate values was collected.
Mean Percent Change From Baseline in Serum Urate Levels at Month 2 Visit.	Baseline and Month 2	Serum urate values were obtained at the Month 2 visit. The percent change in serum urate from baseline to the Month 2 visit was summarized.
Mean Percent Change From Baseline in Serum Urate Levels at Month 4 Visit	Baseline and Month 4	Serum urate values were obtained at the Month 4 visit. The percent change in serum urate from baseline to the Month 4 visit was summarized.
Mean Percent Change From Baseline in Serum Urate Levels at Month 6 Visit.	Baseline and Month 6	Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized.
Mean Percent Change From Baseline in Serum Urate Levels at Final Visit.	Baseline and Last Visit on treatment (up to 6 months)	The percent change in serum urate from baseline to the Final visit was summarized. The final visit was the last visit at which a serum urate value was collected.