NCT01407874

A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: BioCryst Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol in subjects with moderate renal insufficiency.

Conditions

• Gout
• Hyperuricemia
• Arthritis
• Joint Disease
• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	Placebo	Oral dose administered daily for 84 days.
DRUG	Ulodesine (BCX4208) 5 mg	Oral dose administered daily for 84 days.
DRUG	Ulodesine (BCX4208) 10 mg	Oral dose administered daily for 84 days.

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2011-08-02
• Last updated: 2013-11-20

Locations

10 sites across 1 country: United States