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

NCT ID: NCT01109121

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

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Moderate to Severe Gout Hyperuricemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Allopurinol

Allopurinol

Group Type ACTIVE_COMPARATOR

Allopurinol

Intervention Type DRUG

Allopurinol 400 mg, QD

Combination 400

Tranilast and Allopurinol

Group Type EXPERIMENTAL

Combination 400

Intervention Type DRUG

Tranilast 300 mg QD; Allopurinol 400 mg QD

Combination 600

Tranilast and Allopurinol

Group Type EXPERIMENTAL

Combination 600

Intervention Type DRUG

Tranilast, 300 mg QD; Allopurinol 600 mg QD

Interventions

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Combination 400

Tranilast 300 mg QD; Allopurinol 400 mg QD

Intervention Type DRUG

Allopurinol

Allopurinol 400 mg, QD

Intervention Type DRUG

Combination 600

Tranilast, 300 mg QD; Allopurinol 600 mg QD

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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

La Jolla, California, United States

Site Status

Nuon Investigative Site

Santa Maria, California, United States

Site Status

Nuon Investigative Site

Washington D.C., District of Columbia, United States

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Nuon Investigative Site

New Port Richey, Florida, United States

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Nuon Investigative Site

Honolulu, Hawaii, United States

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Boise, Idaho, United States

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Bloomington, Indiana, United States

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Nuon Investigative Site

Owensboro, Kentucky, United States

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Nuon Investigative Site

Baltimore, Maryland, United States

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Nuon Investigative Site

Wheaton, Maryland, United States

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Billings, Montana, United States

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Omaha, Nebraska, United States

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Reno, Nevada, United States

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Nuon Investigative Site

Teaneck, New Jersey, United States

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Nuon Investigative Site

Durham, North Carolina, United States

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Cincinnati, Ohio, United States

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Nuon Investigative Site

Oklahoma City, Oklahoma, United States

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Lake Oswego, Oregon, United States

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Nuon Investigative Site

Duncansville, Pennsylvania, United States

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Nuon Investigative Site

West Reading, Pennsylvania, United States

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Nuon Investigative Site

Charleston, South Carolina, United States

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Nuon Investigative Site

Greenville, South Carolina, United States

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Nuon Investigative Site

Waco, Texas, United States

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Nuon Investigative Site

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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A3007GT

Identifier Type: -

Identifier Source: org_study_id

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