Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02393560
Registration number
NCT02393560
Ethics application status
Date submitted
15/03/2015
Date registered
19/03/2015
Date last updated
25/01/2017
Titles & IDs
Public title
DECT Study in Allopurinol-Treated Gout Patients
Query!
Scientific title
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
Query!
Secondary ID [1]
0
0
ALLO-402
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Gout
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Other muscular and skeletal disorders
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
Description of intervention(s) / exposure
Treatment: Surgery - DECT scan
Gout subjects on stable dose of allopurinol (at least 300mg) -
Treatment: Surgery: DECT scan
Query!
Intervention code [1]
0
0
Treatment: Surgery
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Presence and volume of MSU crystal deposits as determined by DECT imaging
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
8 weeks
Query!
Secondary outcome [1]
0
0
Joint erosion as visualized on DECT images
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
8 weeks
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
85
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key 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.
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Prospective
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/04/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/10/2016
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
223
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Colorado
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Ohio
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Texas
Query!
Country [6]
0
0
New Zealand
Query!
State/province [6]
0
0
Auckland
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Ardea Biosciences, Inc.
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02393560
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Nihar Bhakta, MD
Query!
Address
0
0
Ardea Biosciences, Inc.
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02393560
Download to PDF