Study of Tranilast Alone or in Combination With Allopurinol in Subjects With Hyperuricemia - Full Text View

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:

MedlinePlus related topics: Gout

Drug Information available for: Allopurinol Allopurinol sodium

U.S. FDA Resources

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

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:

Gout
Hyperuricemia
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Pathologic Processes
Allopurinol
Tranilast
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Antimetabolites
Protective Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013