drugset / Trial / NCT02063997

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

NCT02063997 ↗

Phase 2 Completed 248 enrolled Gilead Sciences
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

Start
2014-03
Primary completion
2015-01
Completion
2015-01

Outcome

Met primary endpoint

paper The primary outcome measure comparing flare incidence between 800 mg arhalofenate and 300 mg allopurinol was achieved, with a 46% decrease in the 800 mg arhalofenate group (0.66 versus 1.24; P = 0.0056). PMID 26989892 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Allopurinol Small molecule 300 mg —
Subject Arhalofenate Unknown 600 mg —
Subject Arhalofenate Unknown 800 mg —
Comparator Colchicine Small molecule 0.6 mg —

Indications