A Study to Evaluate Safety and Efficacy of Oral Febuxostat in Patients With Gout

Study Overview
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Brief Summary
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This is a multicenter, open label, randomized, allopurinol-controlled, parallel-design study. Approximately 120 subjects will be randomly assigned in 1:1 ratio to receive febuxostat, or allopurinol for subjects with gout.

Official Title
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A Randomized, Open Label, Multicenter, Allopurinol- Controlled Study to Assess the Safety and Efficacy of Oral Febuxostat in Patients 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: Subjects will also have a history or presence of gout as defined by the American College of Rheumatology (ACR) criteria Subject has serum urate level >= 8.0 mg/dL at the screening Visit Exclusion Criteria: Female subject who is breast-feeding or pregnant Subject has a history of xanthinuria Subject who is intolerant of allopurinol, ie hypersensitivity, Steven-Johnson syndrome/topic epidermal necrolysis Subject who takes allopurinol > 300 mg/day and with serum urate level > 8mg/dL Subject who is HLA B*5801 positive Subject who is receiving thiazide diuretic therapy Subject who has secondary hyperuricemia Subject who requires concurrent therapy with any systemic or topical medications, prescribed or non-prescribed, containing aspirin or other salicylates (low doses of aspirin will be allowed(ie. =< 325mg/day) Subject who requires therapy with prednisone > 10 mg/ day during the study Subject who has active liver disease or hepatic dysfunction, defined as both ALT and AST > 1.5 times the upper limit of normal Subject who has serum creatinine >= 1.5mg/dL Subject who has any another significant medical condition as defined by the investigator that would interfere with the treatment, safety or compliance with the protocol (eg. A clinically significant ECG result) Subject who has a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the study, or has taken any systemic cancer chemotherapy within 5 years prior to the study Subject who has previously participated in a clinical study in which febuxostat was administered Subject who has participated in another investigational trial within the 30 days prior to the study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: febuxostat group<br>oral | Drug: febuxostat<br>* oral<br>* Other names: Adenuric, Uloric, Feburic;|
| Active Comparator: allopurinol group<br>oral | Drug: Allopurinol<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects whose serum urate level decreases to < 6.0 mg/dL |  | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in serum urate levels |  | Baseline and at week 12 | 
| Safety assessed by the incidence of adverse events, physical exam. and vital signs, tabo-tests and 12-lead ECG |  | Baseline and at week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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xanthine oxidase inhibitor, Uric acid lowering drug