Tranilast Plus Allopurinol in Patients With Moderate to Severe Gout (TAnGO) - Full Text View

Purpose

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	Intervention	Phase
Moderate to Severe Gout Hyperuricemia	Drug: Combination 400 Drug: Allopurinol Drug: Combination 600	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

MedlinePlus related topics: Gout

Drug Information available for: Allopurinol Allopurinol sodium

U.S. FDA Resources

Further study details as provided by Nuon Therapeutics, Inc.:

Primary Outcome Measures:

Percent change from baseline in serum uric acid (sUA) levels [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects whose sUA levels fall below 6.0 mg/dL following 4 weeks of dosing [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment:	112
Study Start Date:	June 2010
Study Completion Date:	January 2011
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Allopurinol 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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109121

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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
Nuon Investigative Site
New Port Richey, Florida, United States
United States, Hawaii
Nuon Investigative Site
Honolulu, Hawaii, United States
United States, Idaho
Nuon Investigative Site
Boise, Idaho, United States
United States, Indiana
Nuon Investigative Site
Bloomington, Indiana, United States
United States, Kentucky
Nuon Investigative Site
Owensboro, Kentucky, United States
United States, Maryland
Nuon Investigative Site
Baltimore, Maryland, United States
Nuon Investigative Site
Wheaton, Maryland, United States
United States, Montana
Nuon Investigative Site
Billings, Montana, United States
United States, Nebraska
Nuon Investigative Site
Omaha, Nebraska, United States
United States, Nevada
Nuon Investigative Site
Reno, Nevada, United States
United States, New Jersey
Nuon Investigative Site
Teaneck, New Jersey, United States
United States, North Carolina
Nuon Investigative Site
Durham, North Carolina, United States
United States, Ohio
Nuon Investigative Site
Cincinnati, Ohio, United States
United States, Oklahoma
Nuon Investigative Site
Oklahoma City, Oklahoma, United States
United States, Oregon
Nuon Investigative Site
Lake Oswego, Oregon, United States
United States, Pennsylvania
Nuon Investigative Site
Duncansville, Pennsylvania, United States
Nuon Investigative Site
West Reading, Pennsylvania, United States
United States, South Carolina
Nuon Investigative Site
Charleston, South Carolina, United States
Nuon Investigative Site
Greenville, South Carolina, United States
United States, Texas
Nuon Investigative Site
Waco, Texas, United States
United States, Washington
Nuon Investigative Site
Spokane, Washington, United States

Sponsors and Collaborators

Nuon Therapeutics, Inc.

Investigators

Study Director:

Director, Nuon Clinical Trials Group

Nuon Therapeutics, Inc.

More Information

No publications provided

Responsible Party:	Nuon Therapeutics Clinical Trials Contact, Nuon Therapeutics
ClinicalTrials.gov Identifier:	NCT01109121 History of Changes
Other Study ID Numbers:	A3007GT
Study First Received:	April 21, 2010
Last Updated:	January 5, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Nuon Therapeutics, Inc.:

Moderate to severe gout
Hyperuricemia

Additional relevant MeSH terms:

Gout
Hyperuricemia
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Pathologic Processes
Allopurinol
Tranilast
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Antimetabolites
Protective Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 18, 2013