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

Nuon Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hyperuricemia; Gout

Treatments: Drug: Febuxostat; Drug: Combination - Tranilast and Febuxostat; Drug: Tranilast

Study type: Interventional

Funder types: Industry

Identifiers

NCT00995618

A3006GT

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 3 patient groups

Tranilast

Experimental group

Description:

Tranilast tablets

Treatment:

Drug: Tranilast

Febuxostat

Active Comparator group

Description:

Febuxostat tablets

Treatment:

Drug: Febuxostat

Combination

Experimental group

Description:

Tranilast plus febuxostat

Treatment:

Drug: Combination - Tranilast and Febuxostat