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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01052987

Enrollment

Registered

2010-01-21

Start date

2010-01-31

Completion date

2010-11-30

Last updated

2011-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout, Hyperuricemia

Keywords

Gout, Hyperuricemia

Brief summary

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.

Interventions

DRUGTranilast

Tranilast tablets, 300 mg, QD

DRUGAllopurinol

Allopurinol tablets 300 mg, QD

DRUGCombination - Tranilast and Allopurinol

Tranilast, 300 mg QD; Allopurinol 300 mg QD

DRUG400 mg Allopurinol

400 mg Allopurinol administered once daily for 7 days

DRUGHigh dose combination

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Mean percent decrease in serum uric acid levels	Seven days

Secondary

Measure	Time frame
Analysis of pharmacokinetic parameters (AUC, Cmax) of tranilast, allopurinol and combination	Seven days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026