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Trial registered on ANZCTR


Registration number
ACTRN12613000114741
Ethics application status
Approved
Date submitted
11/12/2012
Date registered
31/01/2013
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The time course and magnitude of allopurinol effect on serum uric acid in patients with gout
Scientific title
Can a better understanding of time course and magnitude of allopurinol effect on serum uric acid provide the basis for a revised dosing strategy whcih will enable more patients to acheive the clinical target for serum uric acid of < 0.36 mmol/L?
Secondary ID [1] 281648 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 287935 0
Condition category
Condition code
Inflammatory and Immune System 288312 288312 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an observational study in patients who are initiating allopurinol for the treatment of gout. Blood sample for the measurement of allopurinol, oxypurinol and uric acid concentrations will be collected on Days 1,2,3,7,14,21 and 28. Patients will be observed for 28 days.
Intervention code [1] 286184 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288484 0
The aim of this study is to collect intensive pharmacokinetic data from the initiation of allopurinol therapy to clarify the time course and magnitude of urate change in relation to the administered dose and to the measured allopurinol and oxypurinol plasma concentrations.
Timepoint [1] 288484 0
Blood samples for the measurement of allopurinol and oxypurinol plasma concentrations and serum uric acid concentrations will be collected at baseline (prior to allopurinol therapy) and at 10-20 minutes, 20-40 minutes, 40-60 minutes, 1 - 2 hours, 2 - 3 hours, and 3 - 6 hours and 6-9 hours after the first dose of allopurinol. On Day 2 of therapy blood samples will be collected prior to the second dose and 2-10 hours after the dose. ON Days 3, 7, 14, 21 and 28 a single blood sample will be collected 2-10 hours after the daily dose of allopurinol. Note that all patients will be receiving allopurinol as part of normal care. The starting dose of allopurinol will be determined by the Rheumatologist and will vary depending on the patients’ co-morbidities.
Secondary outcome [1] 300290 0
Nil
Timepoint [1] 300290 0
Nil

Eligibility
Key inclusion criteria
Patients with gout as defined by the American College of Rheumatology Criteria who are initiating allopurinol as part of routine clinical care.
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who are unable or unwilling to give written informed consent
2. Patients taking concurrent losartan, diuretics or uricosuric agents.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 4740 0
New Zealand
State/province [1] 4740 0
Otago

Funding & Sponsors
Funding source category [1] 286447 0
University
Name [1] 286447 0
University of Otago Research Grant
Address [1] 286447 0
Research and Enterprise, PO Box 56, University of Otago, Dunedin, NZ 9054
Country [1] 286447 0
New Zealand
Primary sponsor type
University
Name
University of Otago Research Grant
Address
Research and Enterprise, PO Box 56, University of Otago, Dunedin, NZ 9054
Country
New Zealand
Secondary sponsor category [1] 285234 0
None
Name [1] 285234 0
Address [1] 285234 0
Country [1] 285234 0
Other collaborator category [1] 277215 0
Individual
Name [1] 277215 0
Assoc Prof Lisa Stamp
Address [1] 277215 0
Department of Medicine, PO Box 4345, University of Otago Christchurch, NZ, 8140
Country [1] 277215 0
New Zealand
Other collaborator category [2] 277216 0
Individual
Name [2] 277216 0
Professor Murray Barclay
Address [2] 277216 0
Department of Medicine, PO Box 4345, University of Otago Christchurch, NZ, 8140
Country [2] 277216 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288527 0
Human Ethics Committee
Ethics committee address [1] 288527 0
Ground floor, Clocktower Building, University of Otago, Dunedin 9054
Ethics committee country [1] 288527 0
New Zealand
Date submitted for ethics approval [1] 288527 0
01/10/2012
Approval date [1] 288527 0
28/11/2012
Ethics approval number [1] 288527 0

Summary
Brief summary
Allopurinol is used to treat gout and works by reducing serum urate concentrations. Current prescribing guidelines frequently result in a suboptimal reduction in urate. This project aims to quantify the time course and magnitude of allopurinol effect on serum urate at the initiation of therapy in relation to plasma drug concentrations and dose. Serum urate and plasma drug concentrations will be measured and used to develop a model that will allow us to predict the probability of successful urate lowering under different dosing regimens. This model will be used to develop a revised dosing strategy in future research.
Trial website
Trial related presentations / publications
Wright DFB, Duffull SB, Merriman TR, Dalbeth N, Barclay ML, Stamp LK. Predicting allopurinol response in patients with gout. Br J Clin Pharmacol. 2016 81(2):277-289.

Wright DFB, Duffull SB, Merriman TR, Dalbeth N, Barclay ML, Stamp LK. Can We Predict the Dose of Allopurinol to Achieve Target Urate? American College of Rheumatology Annual Meeting. Poster abstract number 2347, presented by Lisa Stamp. In: Arthritis & Rheumatology 67(supplement S10), 2015.
Public notes

Contacts
Principal investigator
Name 36510 0
Mr Daniel Wright
Address 36510 0
School of Pharmacy, University of Otago, PO Box 56, Dunedin , New Zealand 9054
Country 36510 0
New Zealand
Phone 36510 0
+6434703476
Fax 36510 0
+6434707275
Email 36510 0
dan.wright@otago.ac.nz
Contact person for public queries
Name 36511 0
A/Prof Lisa Stamp
Address 36511 0
Department of Medicine, University of Otago Christchurch, PO BOX 4345, Christchurch New Zealand 8140
Country 36511 0
New Zealand
Phone 36511 0
+6433640953
Fax 36511 0
Email 36511 0
Lisa.stamp@cdhb.govt.nz
Contact person for scientific queries
Name 36512 0
A/Prof Lisa Stamp
Address 36512 0
Department of Medicine, University of Otago Christchurch, PO BOX 4345, Christchurch New Zealand 8140
Country 36512 0
New Zealand
Phone 36512 0
+6433640953
Fax 36512 0
Email 36512 0
Lisa.stamp@cdhb.govt.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary