NCT02063997

Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Acid in Gout Patients

A Randomized, Double-Blind, Active and Placebo-Controlled Study to Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Acid in Gout Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether arhalofenate is effective in preventing flares and reducing serum uric acid in gout patients.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	Arhalofenate 600 mg	Arhalofenate 600 mg tablets once daily for 12 weeks
DRUG	Allopurinol 300 mg	Allopurinol 300 mg tablets once daily for 12 weeks
DRUG	Colchicine 0.6 mg	Colchicine 0.6 mg over-encapsulated tablets once daily for 12 weeks
DRUG	Placebo	Placebo tablets once daily for 12 weeks
DRUG	Arhalofenate 800 mg	Arhalofenate 800 mg tablets once daily for 12 weeks

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-02-17
• Last updated: 2018-01-29

Locations

56 sites across 3 countries: United States, Canada, Georgia