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

This study has been completed.
Information provided by:
Nuon Therapeutics, Inc. Identifier:
First received: April 21, 2010
Last updated: January 5, 2011
Last verified: January 2011
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
Drug: Combination 400
Drug: Allopurinol
Drug: Combination 600
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
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 ]

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

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
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


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
  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 identifier: NCT01109121

  Show 24 Study Locations
Sponsors and Collaborators
Nuon Therapeutics, Inc.
Study Director: Director, Nuon Clinical Trials Group Nuon Therapeutics, Inc.
  More Information

Responsible Party: Nuon Therapeutics Clinical Trials Contact, Nuon Therapeutics Identifier: NCT01109121     History of Changes
Other Study ID Numbers: A3007GT
Study First Received: April 21, 2010
Last Updated: January 5, 2011

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

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
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
Membrane Transport Modulators processed this record on March 30, 2017