Clinical Trial: Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Crossover, Pharmacodynamic and Pharmacokinetic Drug Interaction Study of Tranilast in Combination With Febuxostat Compared With Tranilast Alone and Febuxostat Alone in Heal

Brief Summary: This is a randomized, double-blind, 3-period crossover phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on febuxostat pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of febuxostat on tranilast PK and PD as measured by reduction in serum uric acid levels.

Detailed Summary:
Sponsor: Nuon Therapeutics, Inc.

Current Primary Outcome: Mean decrease in serum uric acid levels [ Time Frame: Seven days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, febuxostat and combination [ Time Frame: 7 days ]

Original Secondary Outcome: Same as current

Information By: Nuon Therapeutics, Inc.

Dates:
Date Received: October 6, 2009
Date Started: September 2009
Date Completion:
Last Updated: January 5, 2011
Last Verified: January 2011