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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01109121
Recruitment Status : Completed
First Posted : April 22, 2010
Last Update Posted : January 6, 2011
Information provided by:
Nuon Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Moderate to Severe Gout Hyperuricemia Drug: Combination 400 Drug: Allopurinol Drug: Combination 600 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gout

Arm Intervention/treatment
Active Comparator: Allopurinol
Drug: Allopurinol
Allopurinol 400 mg, QD

Experimental: Combination 400
Tranilast and Allopurinol
Drug: Combination 400
Tranilast 300 mg QD; Allopurinol 400 mg QD

Experimental: Combination 600
Tranilast and Allopurinol
Drug: Combination 600
Tranilast, 300 mg QD; Allopurinol 600 mg QD

Primary Outcome Measures :
  1. Percent change from baseline in serum uric acid (sUA) levels [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Proportion of subjects whose sUA levels fall below 6.0 mg/dL following 4 weeks of dosing [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01109121

  Hide Study Locations
United States, California
Nuon Investigative Site
La Jolla, California, United States
Nuon Investigative Site
Santa Maria, California, United States
United States, District of Columbia
Nuon Investigative Site
Washington, District of Columbia, United States
United States, Florida
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New Port Richey, Florida, United States
United States, Hawaii
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Honolulu, Hawaii, United States
United States, Idaho
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Boise, Idaho, United States
United States, Indiana
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Bloomington, Indiana, United States
United States, Kentucky
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Owensboro, Kentucky, United States
United States, Maryland
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Baltimore, Maryland, United States
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Wheaton, Maryland, United States
United States, Montana
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Billings, Montana, United States
United States, Nebraska
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Omaha, Nebraska, United States
United States, Nevada
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Reno, Nevada, United States
United States, New Jersey
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Teaneck, New Jersey, United States
United States, North Carolina
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Durham, North Carolina, United States
United States, Ohio
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Cincinnati, Ohio, United States
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
United States, Oregon
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Lake Oswego, Oregon, United States
United States, Pennsylvania
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Duncansville, Pennsylvania, United States
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West Reading, Pennsylvania, United States
United States, South Carolina
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
United States, Texas
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Waco, Texas, United States
United States, Washington
Nuon Investigative Site
Spokane, Washington, United States
Sponsors and Collaborators
Nuon Therapeutics, Inc.
Study Director: Director, Nuon Clinical Trials Group Nuon Therapeutics, Inc.

Responsible Party: Nuon Therapeutics Clinical Trials Contact, Nuon Therapeutics Identifier: NCT01109121     History of Changes
Other Study ID Numbers: A3007GT
First Posted: April 22, 2010    Key Record Dates
Last Update Posted: January 6, 2011
Last Verified: January 2011

Keywords provided by Nuon Therapeutics, Inc.:
Moderate to severe gout

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Protective Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Calcium Channel Blockers