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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
History of Changes

April 21, 2010
January 5, 2011
June 2010
December 2010   (final data collection date for primary outcome measure)
Percent change from baseline in serum uric acid (sUA) levels [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01109121 on ClinicalTrials.gov Archive Site
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 ]
  • Proportion of subjects whose sUA levels fall below 6.0 mg/dL at the end of Period 1 following 4 weeks of dosing [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects whose sUA levels fall below 6.0 mg/dL at the end of Period 2 following 8 weeks of dosing [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Moderate to Severe Gout
  • Hyperuricemia
  • Drug: Combination 400
    Tranilast 300 mg QD; Allopurinol 400 mg QD
  • Drug: Allopurinol
    Allopurinol 400 mg, QD
  • Drug: Combination 600
    Tranilast, 300 mg QD; Allopurinol 600 mg QD
  • Active Comparator: Allopurinol
    Allopurinol
    Intervention: Drug: Allopurinol
  • Experimental: Combination 400
    Tranilast and Allopurinol
    Intervention: Drug: Combination 400
  • Experimental: Combination 600
    Tranilast and Allopurinol
    Intervention: Drug: Combination 600
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
January 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01109121
A3007GT
No
Nuon Therapeutics Clinical Trials Contact, Nuon Therapeutics
Nuon Therapeutics, Inc.
Not Provided
Study Director: Director, Nuon Clinical Trials Group Nuon Therapeutics, Inc.
Nuon Therapeutics, Inc.
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP