Back to resultsStudy of Tranilast Alone or in Combination With Allopurinol in Subjects With Hyperuricemia
Primary Purpose
Gout, Hyperuricemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tranilast
Allopurinol
Combination - Tranilast and Allopurinol
400 mg Allopurinol
High dose combination
Sponsored by
About this trial
This is an interventional treatment trial for Gout focused on measuring Gout, Hyperuricemia
Eligibility Criteria
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
Sites / Locations
- Nuon Investigative Site
- Nuon Investigative Site
- Nuon Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Arm Label
Tranilast
Allopurinol
Combination
High dose Allopurinol
High dose combination
Arm Description
Tranilast tablets
Allopurinol tablets
Tranilast plus Allopurinol
400 mg Allopurinol
Combination of Tranilast 300 mg and Allopurinol 400 mg
Outcomes
Primary Outcome Measures
Mean percent decrease in serum uric acid levels
Secondary Outcome Measures
Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, allopurinol and combination
Full Information
NCT ID
NCT01052987
First Posted
January 5, 2010
Last Updated
January 5, 2011
Sponsor
Nuon Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01052987
Brief Title
Study of Tranilast Alone or in Combination With Allopurinol in Subjects With Hyperuricemia
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Nuon Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout, Hyperuricemia
Keywords
Gout, Hyperuricemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tranilast
Arm Type
Experimental
Arm Description
Tranilast tablets
Arm Title
Allopurinol
Arm Type
Active Comparator
Arm Description
Allopurinol tablets
Arm Title
Combination
Arm Type
Experimental
Arm Description
Tranilast plus Allopurinol
Arm Title
High dose Allopurinol
Arm Type
Active Comparator
Arm Description
400 mg Allopurinol
Arm Title
High dose combination
Arm Type
Experimental
Arm Description
Combination of Tranilast 300 mg and Allopurinol 400 mg
Intervention Type
Drug
Intervention Name(s)
Tranilast
Intervention Description
Tranilast tablets, 300 mg, QD
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Intervention Description
Allopurinol tablets 300 mg, QD
Intervention Type
Drug
Intervention Name(s)
Combination - Tranilast and Allopurinol
Intervention Description
Tranilast, 300 mg QD; Allopurinol 300 mg QD
Intervention Type
Drug
Intervention Name(s)
400 mg Allopurinol
Intervention Description
400 mg Allopurinol administered once daily for 7 days
Intervention Type
Drug
Intervention Name(s)
High dose combination
Intervention Description
Combination of Tranilast 300 mg once daily for 7 days plus Allopurinol 400 mg once daily for 7 days
Primary Outcome Measure Information:
Title
Mean percent decrease in serum uric acid levels
Time Frame
Seven days
Secondary Outcome Measure Information:
Title
Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, allopurinol and combination
Time Frame
Seven days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Director, Nuon Clinical Trials Group
Organizational Affiliation
Nuon Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Nuon Investigative Site
City
Honolulu
State/Province
Hawaii
Country
United States
Facility Name
Nuon Investigative Site
City
Evansville
State/Province
Indiana
Country
United States
Facility Name
Nuon Investigative Site
City
Dallas
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Tranilast Alone or in Combination With Allopurinol in Subjects With Hyperuricemia
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