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Study of Tranilast Alone or in Combination With Allopurinol in Subjects With Hyperuricemia

This study has been completed.
Sponsor:
Information provided by:
Nuon Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01052987
First received: January 5, 2010
Last updated: January 5, 2011
Last verified: January 2011
History of Changes

January 5, 2010
January 5, 2011
January 2010
June 2010   (final data collection date for primary outcome measure)
Mean percent decrease in serum uric acid levels [ Time Frame: Seven days ] [ Designated as safety issue: No ]
Mean decrease in serum uric acid levels [ Time Frame: Seven days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01052987 on ClinicalTrials.gov Archive Site
Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, allopurinol and combination [ Time Frame: Seven days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Tranilast Alone or in Combination With Allopurinol in Subjects With Hyperuricemia
A Randomized, Double-Blind, Crossover, Pharmacodynamic and Pharmacokinetic Drug Interaction Study of Tranilast in Combination With Allopurinol Compared With Tranilast Alone and Allopurinol Alone in Healthy Subjects With Hyperuricemia

This is a randomized, double-blind, 3-period 3-treatment crossover followed by a 2-period 2-treatment crossover, phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on allopurinol pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of allopurinol 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: Allopurinol
    Allopurinol tablets 300 mg, QD
  • Drug: Combination - Tranilast and Allopurinol
    Tranilast, 300 mg QD; Allopurinol 300 mg QD
  • Drug: 400 mg Allopurinol
    400 mg Allopurinol administered once daily for 7 days
  • Drug: High dose combination
    Combination of Tranilast 300 mg once daily for 7 days plus Allopurinol 400 mg once daily for 7 days
  • Experimental: Tranilast
    Tranilast tablets
    Intervention: Drug: Tranilast
  • Active Comparator: Allopurinol
    Allopurinol tablets
    Intervention: Drug: Allopurinol
  • Experimental: Combination
    Tranilast plus Allopurinol
    Intervention: Drug: Combination - Tranilast and Allopurinol
  • Active Comparator: High dose Allopurinol
    400 mg Allopurinol
    Intervention: Drug: 400 mg Allopurinol
  • Experimental: High dose combination
    Combination of Tranilast 300 mg and Allopurinol 400 mg
    Intervention: Drug: High dose combination
Not Provided

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

Inclusion Criteria:

  • Male or female, aged 21 to 70
  • Subjects with hyperuricemia who are otherwise healthy

Exclusion Criteria:

  • Pregnant or nursing
  • Known history of gout unless approved by the Investigator or Sponsor
  • Clinically significant infection at Screening
  • Known sensitivity to tranilast or allopurinol
Both
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01052987
A3008GT
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