NCT00821392

Phase III Trial of Febuxostat in Korea Gout Patients

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: SK Chemicals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	Febuxostat

Timeline

• Start date: 2006-08-01
• Primary completion: 2007-09-01
• Completion: 2007-09-01
• First posted: 2009-01-13
• Last updated: 2009-01-13