Study of Tranilast Alone or in Combination With Allopurinol in Subjects 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: NCT01052987
Recruitment Status : Completed
First Posted : January 21, 2010
Last Update Posted : January 6, 2011
Information provided by:
Nuon Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Gout Hyperuricemia Drug: Tranilast Drug: Allopurinol Drug: Combination - Tranilast and Allopurinol Drug: 400 mg Allopurinol Drug: High dose combination Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated 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 Allopurinol Compared With Tranilast Alone and Allopurinol Alone in Healthy Subjects With Hyperuricemia
Study Start Date : January 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gout

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

Active Comparator: Allopurinol
Allopurinol tablets
Drug: Allopurinol
Allopurinol tablets 300 mg, QD

Experimental: Combination
Tranilast plus Allopurinol
Drug: Combination - Tranilast and Allopurinol
Tranilast, 300 mg QD; Allopurinol 300 mg QD

Active Comparator: High dose Allopurinol
400 mg Allopurinol
Drug: 400 mg Allopurinol
400 mg Allopurinol administered once daily for 7 days

Experimental: High dose combination
Combination of Tranilast 300 mg and Allopurinol 400 mg
Drug: High dose combination
Combination of Tranilast 300 mg once daily for 7 days plus Allopurinol 400 mg once daily for 7 days

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01052987

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.
Study Director: Director, Nuon Clinical Trials Group Nuon Therapeutics, Inc.

Responsible Party: Nuon Therapeutics Clinical Trials Contact, Nuon Therapeutics Identifier: NCT01052987     History of Changes
Other Study ID Numbers: A3008GT
First Posted: January 21, 2010    Key Record Dates
Last Update Posted: January 6, 2011
Last Verified: January 2011

Keywords provided by Nuon Therapeutics, Inc.:

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