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

NCT00995618 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-01-06

No results posted yet for this study

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.

Conditions

  • Gout
  • Hyperuricemia

Interventions

DRUG

Tranilast

Tranilast tablets, 300 mg, QD

DRUG

Febuxostat

Febuxostat Tablets, 40 mg, QD

DRUG

Combination - Tranilast and Febuxostat

Tranilast, 300 mg QD; Febuxostat, 40 mg QD

Sponsors & Collaborators

  • Nuon Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Director, Nuon Clinical Trials Group · Nuon Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00995618 on ClinicalTrials.gov