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

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)

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.

Study Overview

• Status: Completed
• Conditions: Hyperuricemia; Moderate to Severe Gout
• Intervention / Treatment: Drug: Allopurinol; Drug: Combination 400; Drug: Combination 600

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change from baseline in serum uric acid (sUA) levels	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects whose sUA levels fall below 6.0 mg/dL following 4 weeks of dosing	4 weeks

Collaborators and Investigators

• Sponsor: Nuon Therapeutics, Inc.
• Investigators: Study Director: Director, Nuon Clinical Trials Group, Nuon Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: April 21, 2010
• First Submitted That Met QC Criteria: April 21, 2010
• First Posted (Estimate): April 22, 2010

Study Record Updates

• Last Update Posted (Estimate): January 6, 2011
• Last Update Submitted That Met QC Criteria: January 5, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: Hyperuricemia; Moderate to severe gout
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Hyperuricemia; Gout; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites; Protective Agents; Antioxidants; Free Radical Scavengers; Gout Suppressants; Allopurinol
• Other Study ID Numbers: A3007GT