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Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia

This study has been completed.
Sponsor:
Information provided by:
Nuon Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00995618
First received: October 6, 2009
Last updated: January 5, 2011
Last verified: January 2011

October 6, 2009
January 5, 2011
September 2009
April 2010   (final data collection date for primary outcome measure)
Mean decrease in serum uric acid levels [ Time Frame: Seven days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00995618 on ClinicalTrials.gov Archive Site
Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, febuxostat and combination [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia
A Randomized, Double-Blind, Crossover, Pharmacodynamic and Pharmacokinetic Drug Interaction Study of Tranilast in Combination With Febuxostat Compared With Tranilast Alone and Febuxostat Alone in Healthy Subjects With Hyperuricemia

This is a randomized, double-blind, 3-period crossover phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on febuxostat pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of febuxostat on tranilast PK and PD as measured by reduction in serum uric acid levels.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Gout
  • Hyperuricemia
  • Drug: Tranilast
    Tranilast tablets, 300 mg, QD
  • Drug: Febuxostat
    Febuxostat Tablets, 40 mg, QD
    Other Name: Uloric
  • Drug: Combination - Tranilast and Febuxostat
    Tranilast, 300 mg QD; Febuxostat, 40 mg QD
  • Experimental: Tranilast
    Tranilast tablets
    Intervention: Drug: Tranilast
  • Active Comparator: Febuxostat
    Febuxostat tablets
    Intervention: Drug: Febuxostat
  • Experimental: Combination
    Tranilast plus febuxostat
    Intervention: Drug: Combination - Tranilast and Febuxostat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, aged 18 to 70
  • Subjects with hyperuricemia who are otherwise healthy

Exclusion Criteria:

  • Pregnant or nursing
  • Known history of gout
  • Clinically significant infection at Screening
  • Known sensitivity to tranilast or febuxostat
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00995618
A3006GT
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