Clinical Trial: Study of Tranilast Alone or in Combination With Allopurinol in Subjects 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 Allopurinol Compared With Tranilast Alone and Allopurinol Alone in He

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

Detailed Summary:
Sponsor: Nuon Therapeutics, Inc.

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

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

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

Original Secondary Outcome: Same as current

Information By: Nuon Therapeutics, Inc.

Dates:
Date Received: January 5, 2010
Date Started: January 2010
Date Completion:
Last Updated: January 5, 2011
Last Verified: January 2011