Phase III Trial of Febuxostat in Korea Gout Patients
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
|Study Start Date:||August 2006|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
|Active Comparator: 1 Febuxostat 40mg||Drug: Febuxostat|
|Active Comparator: 2 Febuxostat 80mg||Drug: Febuxostat|
|Active Comparator: 3 Febuxostat 120mg||Drug: Febuxostat|
|Sham Comparator: 4 Allopurinol 300mg||Drug: Febuxostat|
|Placebo Comparator: 5 Placebo||Drug: Febuxostat|
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.