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

January 5, 2011 updated by: Nuon Therapeutics, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tranilast
Tranilast tablets
Drug: Tranilast
Tranilast tablets, 300 mg, QD
Active Comparator: Allopurinol
Allopurinol tablets
Drug: Allopurinol
Allopurinol tablets 300 mg, QD
Experimental: Combination
Tranilast plus Allopurinol
Drug: Combination - Tranilast and Allopurinol
Tranilast, 300 mg QD; Allopurinol 300 mg QD
Active Comparator: High dose Allopurinol
400 mg Allopurinol
Drug: 400 mg Allopurinol
400 mg Allopurinol administered once daily for 7 days
Experimental: High dose combination
Combination of Tranilast 300 mg and Allopurinol 400 mg
Drug: High dose combination
Combination of Tranilast 300 mg once daily for 7 days plus Allopurinol 400 mg once daily for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean percent decrease in serum uric acid levels
Time Frame: Seven days
Seven days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuon Therapeutics, Inc.

Investigators

  • Study Director: Director, Nuon Clinical Trials Group, Nuon Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 19, 2010

First Posted (Estimate)

January 21, 2010

Study Record Updates

Last Update Posted (Estimate)

January 6, 2011

Last Update Submitted That Met QC Criteria

January 5, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3008GT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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