Status:
COMPLETED
Phase III Trial of Febuxostat in Korea Gout Patients
Lead Sponsor:
SK Chemicals Co., Ltd.
Conditions:
Gout
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
This study was designed to evalute the efficacy and safety of Febuxostat after oral administration to patientd with gout in Korea
Detailed Description
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 af...
Eligibility Criteria
Inclusion
- \<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\>
- serum urate level ≥8.0mg/dL 2.creatinine level ≤ 1.5mg/dL 3.subject continued to meet all inclusion and no exclusion criteria
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT00821392
Start Date
August 1 2006
End Date
September 1 2007
Last Update
January 13 2009
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