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Tranilast Plus Allopurinol in Patients With Moderate to Severe Gout (TAnGO)

Primary Purpose

Moderate to Severe Gout, Hyperuricemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Combination 400
Allopurinol
Combination 600
Sponsored by
Nuon Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderate to Severe Gout focused on measuring Moderate to severe gout, Hyperuricemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female, aged 18 to 80
  • Severe gout, demonstrated by 3 or more gout flares in the previous 12 months, or the presence of at least one gout tophus or gouty arthritis
  • Hyperuricemia with a sUA ≥8.0 mg/dL

Exclusion Criteria:

  • Pregnant or nursing
  • Known hypersensitivity to any of the components of tranilast or allopurinol
  • Known history of xanthinuria or kidney stones
  • Use of an investigational drug within 30 days
  • Presence of, or history of, cancer with the exception of completely excised, non-metastatic squamous cell and basal cell carcinomas of the skin
  • Subject is planning or likely to require a surgical procedure during the study

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Allopurinol

Combination 400

Combination 600

Arm Description

Allopurinol

Tranilast and Allopurinol

Tranilast and Allopurinol

Outcomes

Primary Outcome Measures

Percent change from baseline in serum uric acid (sUA) levels

Secondary Outcome Measures

Proportion of subjects whose sUA levels fall below 6.0 mg/dL following 4 weeks of dosing

Full Information

First Posted
April 21, 2010
Last Updated
January 5, 2011
Sponsor
Nuon Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01109121
Brief Title
Tranilast Plus Allopurinol in Patients With Moderate to Severe Gout (TAnGO)
Official Title
A Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Tranilast in Combination With Allopurinol in Patients With Moderate to Severe Gout (TAnGO)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nuon Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This Phase 2 study will be a multicenter, double-blind, randomized, active-comparator study to evaluate the safety and efficacy of tranilast in combination with allopurinol in patients with hyperuricemia and moderate to severe gout.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate to Severe Gout, Hyperuricemia
Keywords
Moderate to severe gout, Hyperuricemia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Allopurinol
Arm Type
Active Comparator
Arm Description
Allopurinol
Arm Title
Combination 400
Arm Type
Experimental
Arm Description
Tranilast and Allopurinol
Arm Title
Combination 600
Arm Type
Experimental
Arm Description
Tranilast and Allopurinol
Intervention Type
Drug
Intervention Name(s)
Combination 400
Intervention Description
Tranilast 300 mg QD; Allopurinol 400 mg QD
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Intervention Description
Allopurinol 400 mg, QD
Intervention Type
Drug
Intervention Name(s)
Combination 600
Intervention Description
Tranilast, 300 mg QD; Allopurinol 600 mg QD
Primary Outcome Measure Information:
Title
Percent change from baseline in serum uric acid (sUA) levels
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Proportion of subjects whose sUA levels fall below 6.0 mg/dL following 4 weeks of dosing
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, aged 18 to 80 Severe gout, demonstrated by 3 or more gout flares in the previous 12 months, or the presence of at least one gout tophus or gouty arthritis Hyperuricemia with a sUA ≥8.0 mg/dL Exclusion Criteria: Pregnant or nursing Known hypersensitivity to any of the components of tranilast or allopurinol Known history of xanthinuria or kidney stones Use of an investigational drug within 30 days Presence of, or history of, cancer with the exception of completely excised, non-metastatic squamous cell and basal cell carcinomas of the skin Subject is planning or likely to require a surgical procedure during the study
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
La Jolla
State/Province
California
Country
United States
Facility Name
Nuon Investigative Site
City
Santa Maria
State/Province
California
Country
United States
Facility Name
Nuon Investigative Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Nuon Investigative Site
City
New Port Richey
State/Province
Florida
Country
United States
Facility Name
Nuon Investigative Site
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Nuon Investigative Site
City
Boise
State/Province
Idaho
Country
United States
Facility Name
Nuon Investigative Site
City
Bloomington
State/Province
Indiana
Country
United States
Facility Name
Nuon Investigative Site
City
Owensboro
State/Province
Kentucky
Country
United States
Facility Name
Nuon Investigative Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Nuon Investigative Site
City
Wheaton
State/Province
Maryland
Country
United States
Facility Name
Nuon Investigative Site
City
Billings
State/Province
Montana
Country
United States
Facility Name
Nuon Investigative Site
City
Omaha
State/Province
Nebraska
Country
United States
Facility Name
Nuon Investigative Site
City
Reno
State/Province
Nevada
Country
United States
Facility Name
Nuon Investigative Site
City
Teaneck
State/Province
New Jersey
Country
United States
Facility Name
Nuon Investigative Site
City
Durham
State/Province
North Carolina
Country
United States
Facility Name
Nuon Investigative Site
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Nuon Investigative Site
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Nuon Investigative Site
City
Lake Oswego
State/Province
Oregon
Country
United States
Facility Name
Nuon Investigative Site
City
Duncansville
State/Province
Pennsylvania
Country
United States
Facility Name
Nuon Investigative Site
City
West Reading
State/Province
Pennsylvania
Country
United States
Facility Name
Nuon Investigative Site
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Nuon Investigative Site
City
Greenville
State/Province
South Carolina
Country
United States
Facility Name
Nuon Investigative Site
City
Waco
State/Province
Texas
Country
United States
Facility Name
Nuon Investigative Site
City
Spokane
State/Province
Washington
Country
United States

12. IPD Sharing Statement

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Tranilast Plus Allopurinol in Patients With Moderate to Severe Gout (TAnGO)

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