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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01109121
First Posted: April 22, 2010
Last Update Posted: January 6, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nuon Therapeutics, Inc.
April 21, 2010
April 22, 2010
January 6, 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 ]
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 ]
  • 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 ]
  • 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 ]
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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01109121
A3007GT
No
Not Provided
Not Provided
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