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

This study has been completed.
Sponsor:
Information provided by:
Nuon Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01109121
First received: April 21, 2010
Last updated: January 5, 2011
Last verified: January 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
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 August 21, 2014