NCT01399008

Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout Patients

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of MBX-102 in Combination With Allopurinol in Gout Patients With an Inadequate Hypouricemic Response to Allopurinol Alone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of MBX-102 in combination with allopurinol compared to allopurinol alone when administered orally once a day for four weeks to gout patients with an inadequate hypouricemic response to allopurinol alone.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	Arhalofenate	Arhalofenate 400 and 600 mgs over-encapsulated tablets once daily for 4 weeks or Allopurinol 300 mg once daily for 4 weeks
DRUG	Allopurinol	Allopurinol 300 mg as active comparator
DRUG	Colchicine	0.6 mg colchicine daily as flare prophylaxis
DRUG	Placebo	Placebo

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2011-07-21
• Last updated: 2015-09-18
• Results posted: 2014-07-28

Locations

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