Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia

Phase 2

Completed

• Conditions: Gout; Hyperuricemia
• Interventions: Drug: Tranilast; Drug: Febuxostat; Drug: Combination - Tranilast and Febuxostat

• Registration Number: NCT00995618
• Lead Sponsor: Nuon Therapeutics, Inc.

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 Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-06
• Study First Submitted QC: 2009-10-13
• Study First Posted: 2009-10-15
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-05
• Last Update Posted: 2011-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Male or female, aged 18 to 70
• Subjects with hyperuricemia who are otherwise healthy

Exclusion Criteria

• Pregnant or nursing
• Known history of gout
• Clinically significant infection at Screening
• Known sensitivity to tranilast or febuxostat

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tranilast	Tranilast	Tranilast tablets
Febuxostat	Febuxostat	Febuxostat tablets
Combination	Combination - Tranilast and Febuxostat	Tranilast plus febuxostat

Primary Outcome Measures

Name	Time	Method
Mean decrease in serum uric acid levels	Seven days

Secondary Outcome Measures

Name	Time	Method
Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, febuxostat and combination	7 days

Trial Locations

Locations (1)

Nuon Investigative Site; 🇺🇸 Dallas, Texas, United States