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

NCT ID: NCT00995618

Last Updated: 2011-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-04-30

Brief Summary

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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

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Conditions

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Gout Hyperuricemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Tranilast

Tranilast tablets

Group Type EXPERIMENTAL

Tranilast

Intervention Type DRUG

Tranilast tablets, 300 mg, QD

Febuxostat

Febuxostat tablets

Group Type ACTIVE_COMPARATOR

Febuxostat

Intervention Type DRUG

Febuxostat Tablets, 40 mg, QD

Combination

Tranilast plus febuxostat

Group Type EXPERIMENTAL

Combination - Tranilast and Febuxostat

Intervention Type DRUG

Tranilast, 300 mg QD; Febuxostat, 40 mg QD

Interventions

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Tranilast

Tranilast tablets, 300 mg, QD

Intervention Type DRUG

Febuxostat

Febuxostat Tablets, 40 mg, QD

Intervention Type DRUG

Combination - Tranilast and Febuxostat

Tranilast, 300 mg QD; Febuxostat, 40 mg QD

Intervention Type DRUG

Other Intervention Names

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Uloric

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nuon Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Nuon Therapeutics

Principal Investigators

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Director, Nuon Clinical Trials Group

Role: STUDY_DIRECTOR

Nuon Therapeutics, Inc.

Locations

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Nuon Investigative Site

Honolulu, Hawaii, United States

Site Status

Nuon Investigative Site

Evansville, Indiana, United States

Site Status

Nuon Investigative Site

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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A3006GT

Identifier Type: -

Identifier Source: org_study_id

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