- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00995618
Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia
January 5, 2011 updated by: Nuon Therapeutics, Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hawaii
-
Honolulu, Hawaii, United States
- Nuon Investigative Site
-
-
Indiana
-
Evansville, Indiana, United States
- Nuon Investigative Site
-
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Texas
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Dallas, Texas, United States
- Nuon Investigative Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tranilast
Tranilast tablets
|
Tranilast tablets, 300 mg, QD
|
Active Comparator: Febuxostat
Febuxostat tablets
|
Febuxostat Tablets, 40 mg, QD
Other Names:
|
Experimental: Combination
Tranilast plus febuxostat
|
Tranilast, 300 mg QD; Febuxostat, 40 mg QD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean decrease in serum uric acid levels
Time Frame: Seven days
|
Seven days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, febuxostat and combination
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Director, Nuon Clinical Trials Group, Nuon Therapeutics, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
October 6, 2009
First Submitted That Met QC Criteria
October 13, 2009
First Posted (Estimate)
October 15, 2009
Study Record Updates
Last Update Posted (Estimate)
January 6, 2011
Last Update Submitted That Met QC Criteria
January 5, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Hyperuricemia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Platelet Aggregation Inhibitors
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Gout Suppressants
- Febuxostat
- Tranilast
Other Study ID Numbers
- A3006GT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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