Phase III Trial of Febuxostat in Korea Gout Patients

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.

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