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

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. Identifier: NCT00995618
Recruitment Status : Completed
First Posted : October 15, 2009
Last Update Posted : January 6, 2011
Information provided by:
Nuon Therapeutics, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gout Hyperuricemia Drug: Tranilast Drug: Febuxostat Drug: Combination - Tranilast and Febuxostat Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout
Drug Information available for: Febuxostat

Arm Intervention/treatment
Experimental: Tranilast
Tranilast tablets
Drug: Tranilast
Tranilast tablets, 300 mg, QD

Active Comparator: Febuxostat
Febuxostat tablets
Drug: Febuxostat
Febuxostat Tablets, 40 mg, QD
Other Name: Uloric

Experimental: Combination
Tranilast plus febuxostat
Drug: Combination - Tranilast and Febuxostat
Tranilast, 300 mg QD; Febuxostat, 40 mg QD

Primary Outcome Measures :
  1. Mean decrease in serum uric acid levels [ Time Frame: Seven days ]

Secondary Outcome Measures :
  1. Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, febuxostat and combination [ Time Frame: 7 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00995618

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United States, Hawaii
Nuon Investigative Site
Honolulu, Hawaii, United States
United States, Indiana
Nuon Investigative Site
Evansville, Indiana, United States
United States, Texas
Nuon Investigative Site
Dallas, Texas, United States
Sponsors and Collaborators
Nuon Therapeutics, Inc.
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Study Director: Director, Nuon Clinical Trials Group Nuon Therapeutics, Inc.

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Responsible Party: Nuon Therapeutics Clinical Trials Contact, Nuon Therapeutics Identifier: NCT00995618     History of Changes
Other Study ID Numbers: A3006GT
First Posted: October 15, 2009    Key Record Dates
Last Update Posted: January 6, 2011
Last Verified: January 2011

Keywords provided by Nuon Therapeutics, Inc.:

Additional relevant MeSH terms:
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Pathologic Processes
Gout Suppressants
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Platelet Aggregation Inhibitors
Anti-Allergic Agents