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

Completed · Phase 2

Conditions studied: Gout, Hyperuricemia

In brief

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.

Key facts

Study ID

NCT01052987

Run by

Nuon Therapeutics, Inc.

People needed

24

Starts

2010-01-01

Expected to finish

2010-11-01

Last updated by the study team

2011-01-06

Who can join

Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, aged 21 to 70
• Subjects with hyperuricemia who are otherwise healthy

You may not qualify if…

• 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

Where it is running

• Nuon Investigative Site — Honolulu, Hawaii, United States
• Nuon Investigative Site — Evansville, Indiana, United States
• Nuon Investigative Site — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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