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

Nuon Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hyperuricemia; Gout

Treatments: Drug: High dose combination; Drug: Combination - Tranilast and Allopurinol; Drug: Tranilast; Drug: Allopurinol; Drug: 400 mg Allopurinol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01052987

A3008GT

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 5 patient groups

Tranilast

Experimental group

Description:

Tranilast tablets

Treatment:

Drug: Tranilast

Allopurinol

Active Comparator group

Description:

Allopurinol tablets

Treatment:

Drug: Allopurinol

Combination

Experimental group

Description:

Tranilast plus Allopurinol

Treatment:

Drug: Combination - Tranilast and Allopurinol

High dose Allopurinol

Active Comparator group

Description:

400 mg Allopurinol

Treatment:

Drug: 400 mg Allopurinol

High dose combination

Experimental group

Description:

Combination of Tranilast 300 mg and Allopurinol 400 mg

Treatment:

Drug: High dose combination