MedTrace Logo

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

NCT01052987 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-01-06

No results posted yet for this study

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.

Conditions

  • Gout
  • Hyperuricemia

Interventions

DRUG

Tranilast

Tranilast tablets, 300 mg, QD

DRUG

Allopurinol

Allopurinol tablets 300 mg, QD

DRUG

Combination - Tranilast and Allopurinol

Tranilast, 300 mg QD; Allopurinol 300 mg QD

DRUG

400 mg Allopurinol

400 mg Allopurinol administered once daily for 7 days

DRUG

High dose combination

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

Sponsors & Collaborators

  • Nuon Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Director, Nuon Clinical Trials Group · Nuon Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-06-30
Completion
2010-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01052987 on ClinicalTrials.gov