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

This study has been completed.
Sponsor:
Information provided by:
Nuon Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00995618
First received: October 6, 2009
Last updated: January 5, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Gout
Hyperuricemia
Drug: Tranilast
Drug: Febuxostat
Drug: Combination - Tranilast and Febuxostat
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 Febuxostat Compared With Tranilast Alone and Febuxostat Alone in Healthy Subjects With Hyperuricemia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Mean 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, febuxostat and combination [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: September 2009
Study Completion Date: April 2010
Primary Completion Date: April 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: 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00995618

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: NCT00995618     History of Changes
Other Study ID Numbers: A3006GT
Study First Received: October 6, 2009
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:
Gout
Hyperuricemia
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Pathologic Processes
Tranilast
Febuxostat
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on August 19, 2014