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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
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Nuon Therapeutics, Inc.:

Primary Outcome Measures:
  • Mean percent decrease in serum uric acid levels [ Time Frame: Seven days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, allopurinol and combination [ Time Frame: Seven days ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2010
Study Completion Date: November 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052987

Locations
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.
Investigators
Study Director: Director, Nuon Clinical Trials Group Nuon Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Nuon Therapeutics Clinical Trials Contact, Nuon Therapeutics
ClinicalTrials.gov Identifier: NCT01052987     History of Changes
Other Study ID Numbers: A3008GT
Study First Received: January 5, 2010
Last Updated: January 5, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Nuon Therapeutics, Inc.:
Gout
Hyperuricemia

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

ClinicalTrials.gov processed this record on November 24, 2014