Gout Clinical Trial
Official title:
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
This study was designed to evalute the efficacy and safety of Febuxostat after oral administration to patientd with gout in Korea
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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