Phase III Trial of Febuxostat in Korea Gout Patients

Study Overview
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Brief Summary
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This study was designed to evalute the efficacy and safety of Febuxostat after oral administration to patientd with gout in Korea

Detailed Description
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This is a multi-center, randomized, double-blind, allopurinol and placebo controlled, parallel, 5 arms, dose response, bridging study of 4 weeks duration. If subjects pass the screening evaluation after submitting a signed informed consent, they will be randomly assigned to one of the five treatment regimens; febuxostat 40mg, 80mg, 120mg, placebo or allopurinol 300mg. Colchicine 0.6mg QDis given to minimize the risk of gout flares during the washout/run-in period and during the double study period.

Official Title
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A Randomized, Multi-Center, Double Blinded, Allopurinol-Controlled, Placebo-Controlled Parallel Group, 5-Arm, Dose-Response,Bridging Study to Assess the Efficacy and Safety of Febuxostat in Subject With Gout

Conditions
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Gout

Intervention / Treatment
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* Drug: Febuxostat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: <Day -14> age :18-85 years female: either post-menopausal for at least 2 years, surgically sterile, or using a medically accepted means of contraception female: negative serum pregnancy test subjects who satisfy ARA (American Rheumatism Association) subjects must have a renal function defined as: serum creatinine ≤ 1.5 mg/dL <Day -1> 1.serum urate level ≥8.0mg/dL 2.creatinine level ≤ 1.5mg/dL 3.subject continued to meet all inclusion and no exclusion criteria Exclusion Criteria: women who are breast-feeding or pregnant a history of xanthinuria allopurinol intolerance receiving thiazide diuretic therapy secondary hyperuricemia required > 10mg/day of prednisone during the study stable dose(≤10mg/day), inhaled and intranasal steroids will be allowed. concomitant therapy containing aspirin or other salicylates(systemic or topical, prescribed or non-prescribed) stable, low doses aspirin will be allowed(i.e. ≤325mg/day). any change in hormone replacement therapy or oral contraceptive therapy within 3 months of the screening visit alcohol intake≥ 14drinks/week alcohol abuse within 5 years or current excessive alcohol use was prohibited. concomitant therapy with any urate-lowering therapy active liver disease or hepatic dysfunction : ALT, AST ≥1.5 ULN subject was unable to take colchicine or contradictory to colchicine a serum urate level < 8.0mg/dL and not taking uric acid lowering therapy rheumatoid arthritis or any active arthritis requiring for the medication treatment a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the screening visit, or had taken any systemic cancer chemotherapy within 5 years prior to the screening visit participated in another investigational trial within the 30days prior to the screening visit any other significant medical condition as defined by the investigator

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Active Comparator: 1 Febuxostat 40mg<br> | Drug: Febuxostat<br> <br> |
| Active Comparator: 2 Febuxostat 80mg<br> | Drug: Febuxostat<br> <br> |
| Active Comparator: 3 Febuxostat 120mg<br> | Drug: Febuxostat<br> <br> |
| Sham Comparator: 4 Allopurinol 300mg<br> | Drug: Febuxostat<br> <br> |
| Placebo Comparator: 5 Placebo<br> | Drug: Febuxostat<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |