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Completed

NCT Number: NCT01052987

Study of Tranilast Alone or in Combination With Allopurinol in Subjects With Hyperuricemia

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.

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Key information

Conditions

Gout Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Hyperuricemia Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nuon Investigative Site, Honolulu, Hawaii, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranilast

Drug

Tranilast tablets, 300 mg, QD

Allopurinol

Drug

Allopurinol tablets 300 mg, QD

Combination - Tranilast and Allopurinol

Drug

Tranilast, 300 mg QD; Allopurinol 300 mg QD

400 mg Allopurinol

Drug

400 mg Allopurinol administered once daily for 7 days

High dose combination

Drug

Combination of Tranilast 300 mg once daily for 7 days plus Allopurinol 400 mg once daily for 7 days

Primary outcomes

  1. Mean percent decrease in serum uric acid levels

    Time frame: Seven days

Secondary outcomes

  1. Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, allopurinol and combination

    Time frame: Seven days

Sponsors and collaborators

Lead sponsor

Nuon Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 21, 2010
Registry last updated
Jan 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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