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

A Randomized, Open Label, Multicenter, Allopurinol- Controlled Study to Assess the Safety and Efficacy of Oral Febuxostat in Patients With Gout

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.

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