Safety and Efficacy of Oral Febuxostat in Subjects With Gout

Study Overview
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Brief Summary
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The purpose of this study is to compare febuxostat allopurinol in subjects with gout.

Detailed Description
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A randomized, double-blind, multicenter, allopurinol-controlled and parallel-assigned study comparing 40 mg, 80 mg of febuxostat, and allopurinol 300 mg in subjects with gout. Subjects will receive treatment for 24 weeks.

Official Title
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A Phase 3, Randomized, Multicenter, Allopurinol-Controlled Study Assessing the Safety and Efficacy of Oral Febuxostat in Subjects With Gout

Conditions
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Gout

Intervention / Treatment
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* Drug: Febuxostat
* Drug: Allopurinol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hyperuricemia (serum urate ≥8.0 mg/dL) and gout by Chinese 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 Cockcroft and Gault formula; No gout flare 2 weeks beforehand during 2-week screening period. Exclusion Criteria: 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 active liver disease, or hepatic dysfunction; A history of bronchial asthma; A history of renal calculi or thyroid disease; Secondary gout Joint diseases induced by rheumatoid arthritis, psoriatic arthritis and bone tumor; Intolerance to allopurinol and Ibuprofen; Alcohol intake of ≥ 14 drinks/week; Clinically significant medical condition.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Febuxostat 40 mg QD<br>Febuxostat 40 mg, orally, once daily for up to 24 weeks | Drug: Febuxostat<br> <br> |
| Experimental: Febuxostat 80 mg QD<br>Febuxostat 80 mg, orally, once daily for up to 24 weeks | Drug: Febuxostat<br> <br> |
| Active Comparator: Allopurinol 100mg QD<br>Allopurinol 100mg, orally, three times daily for up to 24 weeks | Drug: Allopurinol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 26) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects Whose Serum Urate Levels Are <6.0 mg/dL at Final Visit |  | Final Visit (up to 26 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gout, Uric Acid, Xanthine oxidase, Febuxostat