DECT Study in Allopurinol-Treated Gout Patients

January 24, 2017 updated by: Ardea Biosciences, Inc.

A Study to Determine the Presence and Volume of Monosodium Urate Crystals as Assessed by Dual-Energy Computed Tomography in Gout Patients Treated With Allopurinol

The purpose of this study is to determine presence and volume of monosodium urate (MSU) crystal deposits as determined by dual-energy computed tomography (DECT) imaging in gout subjects treated with allopurinol with and without visible tophi.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

DECT is a technique that enables visualization of MSU crystal deposits by analysis of the chemical composition of the scanned materials. This study will determine the extent of MSU crystal volume in the hands/wrists, feet/ankles, and knees as determined by DECT of subjects with gout taking a dose of at least 300 mg allopurinol daily for the past 12 weeks.

Patients with gout on allopurinol with and without tophi to be assessed using DECT imaging for crystal deposition with assessments, which include patient and provider assessments of disease severity and pain, prior to and after the scan.

Study Type

Observational

Enrollment (Actual)

223

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

  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1023
  • United States
    • California
      • Irvine, California, United States, 92618
    • Colorado
      • Englewood, Colorado, United States, 80113
      • Wheat Ridge, Colorado, United States, 80033
    • Georgia
      • Atlanta, Georgia, United States, 30328
    • Ohio
      • Cleveland, Ohio, United States, 44122
      • Lyndhurst, Ohio, United States, 44124
      • Willoughby Hills, Ohio, United States, 44094
    • Texas
      • Dallas, Texas, United States, 75231
      • Plano, Texas, United States, 75075

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Gout subjects taking a stable dose of at least 300 mg allopurinol daily for at least 12 weeks prior to Day 1 as the sole urate-lowering therapy

Description

Inclusion Criteria:

  • Subject is able to understand the study procedures, the risks involved and willing to provide written informed consent before the first study related activity.
  • Subject is willing to adhere to the visit/protocol schedules.
  • Subject meets the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
  • Subject has been taking allopurinol at a dose of at least 300 mg daily for at least 12 weeks prior to Day 1, as the sole uratelowering therapy.

Exclusion Criteria:

  • Subject who is pregnant or breastfeeding.
  • Subject with any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements (including dual energy computed tomography imaging), or to complete the study.
  • Subject who has received an investigational therapy or has participated in any clinical trial or research study within 30 days of Day 1.
  • Subject who has taken pegloticase (KRYSTEXXA®) or is expected to take pegloticase during the study.

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gout subjects on stable dose of allopurinol (at least 300mg)
Procedure: DECT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence and volume of MSU crystal deposits as determined by DECT imaging
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Joint erosion as visualized on DECT images
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Ardea Biosciences, 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

April 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 15, 2015

First Submitted That Met QC Criteria

March 15, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Estimate)

January 25, 2017

Last Update Submitted That Met QC Criteria

January 24, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALLO-402

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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