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

Primary Purpose

Gout, Hyperuricemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tranilast
Febuxostat
Combination - Tranilast and Febuxostat
Sponsored by
Nuon Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout focused on measuring Gout, Hyperuricemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nuon Investigative Site
  • Nuon Investigative Site
  • Nuon Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Tranilast

Febuxostat

Combination

Arm Description

Tranilast tablets

Febuxostat tablets

Tranilast plus febuxostat

Outcomes

Primary Outcome Measures

Mean decrease in serum uric acid levels

Secondary Outcome Measures

Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, febuxostat and combination

Full Information

First Posted
October 6, 2009
Last Updated
January 5, 2011
Sponsor
Nuon Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00995618
Brief Title
Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia
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 Healthy Subjects With Hyperuricemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nuon Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout, Hyperuricemia
Keywords
Gout, Hyperuricemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranilast
Arm Type
Experimental
Arm Description
Tranilast tablets
Arm Title
Febuxostat
Arm Type
Active Comparator
Arm Description
Febuxostat tablets
Arm Title
Combination
Arm Type
Experimental
Arm Description
Tranilast plus febuxostat
Intervention Type
Drug
Intervention Name(s)
Tranilast
Intervention Description
Tranilast tablets, 300 mg, QD
Intervention Type
Drug
Intervention Name(s)
Febuxostat
Other Intervention Name(s)
Uloric
Intervention Description
Febuxostat Tablets, 40 mg, QD
Intervention Type
Drug
Intervention Name(s)
Combination - Tranilast and Febuxostat
Intervention Description
Tranilast, 300 mg QD; Febuxostat, 40 mg QD
Primary Outcome Measure Information:
Title
Mean decrease in serum uric acid levels
Time Frame
Seven days
Secondary Outcome Measure Information:
Title
Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, febuxostat and combination
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Director, Nuon Clinical Trials Group
Organizational Affiliation
Nuon Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Nuon Investigative Site
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Nuon Investigative Site
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
Nuon Investigative Site
City
Dallas
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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