drugset / Trial / NCT01265264

Study to Evaluate sUA Lowering Activity, Safety and Efficacy of Oral Ulodesine Added to Allopurinol

NCT01265264 ↗

Phase 2 Completed 279 enrolled BioCryst Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine whether ulodesine and allopurinol combined for 12 weeks are effective in treating gout in patients who are not adequately responding to allopurinol alone.

Timeline

Start
2010-12
Primary completion
2012-07
Completion
2013-02

Outcome

Met primary endpoint

release “The primary endpoint of the study was successfully achieved. When added to allopurinol 300 mg, BCX4208 was superior to allopurinol plus placebo” biocryst.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Ulodesine Small molecule 5 mg Oral
Subject Ulodesine Small molecule 10 mg Oral
Subject Ulodesine Small molecule 20 mg Oral
Subject Ulodesine Small molecule 40 mg Oral