Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001188820
Ethics application status
Approved
Date submitted
27/09/2012
Date registered
12/11/2012
Date last updated
12/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and efficacy of immediate versus delayed allopurinol treatment for the prevention of gout flares in pacific, maori and other people
Scientific title
Immediate versus delayed for two weeks allopurinol treatment for the prevention of gout flares in pacific people, maori and other people with outcomes at 6 weeks of pain and at 13 weeks of pain and uric acid serum levels.
Secondary ID [1] 281312 0
Nil
Universal Trial Number (UTN)
nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gout 287524 0
Condition category
Condition code
Musculoskeletal 287846 287846 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 287847 287847 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will enrol 200 participants with gout. Subjects will be randomized to one of two treatments lasting three months:
1. Intervention groups: Immediate opon presentation of an acute flare oral allopurinol given at a dosage depending on the participant’s kidney function level (calculated at 1.5mg/unit eGFR) (maximum dose 150 mg daily) will be given for 10 weeks and then doubled for the next 4 weeks. . Also for the control of acute attacks Prednisone will be given as following: 40mg of prednisone for four days and 20 mg for four days followed by 10mg for three days and 5mg for three days. All together Prednisone will be given for 14 days starting on day 1. 500 micrograms of colchicine will be given twice daily to prevent flares for three and a half months from the start of the study. All medications are in a tablet form.
Intervention code [1] 285774 0
Treatment: Drugs
Intervention code [2] 285942 0
Prevention
Comparator / control treatment
2. Control group: Delayed (by two weeks from the end of the flare i.e. when pain score < 3 ) allopurinol given at a dosage depending on the participant’s kidney function level (calculated at 1.5mg/unit eGFR) will be given for 8 weeks and then doubled for the next 4 weeks. Also for the control of acute attacks Prednisone will be given as following: 40mg of prednisone for four days and 20 mg for four days followed by 10mg for three days and 5mg for three days. It will start at the beginning of a pain flare. All together Prednisone will be given for 14 days .500 micrograms of colchicine will be given twice daily to prevent flares for three and a half months from the start of the study.
Control group
Active

Outcomes
Primary outcome [1] 288067 0
Pain at 6 weeks is the primary outcome. Pain is assessed using a visual analogue scale.
Timepoint [1] 288067 0
6 weeks
Primary outcome [2] 288068 0
Frequency of gout flares (requiring treatment) is not different between the two groups as assessed by using visual analogue scale.
Timepoint [2] 288068 0
6 weeks
Secondary outcome [1] 299366 0
To determine whether the average compliance with consuming allopurinol is the same at 3 months (pill check where possible). Where a pill count is not possible a self-report diary will be used.
Timepoint [1] 299366 0
3 months
Secondary outcome [2] 299367 0
The number of people remaining on allopurinol at three months.
Timepoint [2] 299367 0
3 months
Secondary outcome [3] 299368 0
The proportion of people with serum urate < 0.36 mmol/l at the last visit compared between groups.
Timepoint [3] 299368 0
3 months
Secondary outcome [4] 299369 0
The number of participants requiring rescue treatment for a flare.
Timepoint [4] 299369 0
3 months
Secondary outcome [5] 299370 0
Interviewing some of the participants about their experiences before during and after the study. These will be recorded by audiotape.
Timepoint [5] 299370 0
After 14 weeks.
Secondary outcome [6] 299371 0
Ascertaining how the participants learnt about the study-measured at baseline.
Timepoint [6] 299371 0
at enrolment

Eligibility
Key inclusion criteria
Participants will be adults from 18-75 years old.Speak sufficient English (or have an interpreter).
Have had an attack in the same joint on at least one previous occasion and been seen by a doctor who made the diagnosis of gout using the American College of Rheumatologists (ACR) Criterion.
Can understand the study information sheet to enable them to sign the ethics form (which will be in English, Samoan and Tongan).
Pain level > 3 on the self reported Visual Analogue Scale (Likert Scale) as per participant’s self reporting. We will record the patient's ethnicity but not their nationality
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Insulin dependent diabetes mellitus.
Imminent Renal Failure (on dialysis).
Terminal health condition.
Congestive heart failure other than with the direct involvement of their GP.
Random blood sugar > 15 mmol/L.
Blood pressure < 100 mmHg Hg systolic, pulse > 100, temperature > 37.0.
Total inability to move the affected joint due to pain.
Steroid/colchicine use within the previous week.
Already taking allopurinol.
Development of a skin rash when taking allopurinol.
Pregnant now or planning a pregnancy soon (in 2-3 months)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be done using caseweaver.com. This is office based software that allows concealed randomisation to occure.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 4575 0
New Zealand
State/province [1] 4575 0

Funding & Sponsors
Funding source category [1] 286069 0
Charities/Societies/Foundations
Name [1] 286069 0
Pacific Perspectives Limited
Country [1] 286069 0
New Zealand
Primary sponsor type
University
Name
Department of General Practice and Primary Health Care, School of Population Health, University of Auckland
Address
Department of General Practice and Primary Health Care
University of Auckland
Private Bag 92019
Auckland 1142
261 Morrin Road Glen Innes Auckland New Zealand 1142
Country
New Zealand
Secondary sponsor category [1] 284885 0
None
Name [1] 284885 0
Address [1] 284885 0
Country [1] 284885 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288120 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 288120 0
Health and Disability Ethics Committee
PO Box 5013
Wellington
4213
Ethics committee country [1] 288120 0
New Zealand
Date submitted for ethics approval [1] 288120 0
Approval date [1] 288120 0
03/08/2012
Ethics approval number [1] 288120 0
NTX/12/06/053

Summary
Brief summary
The study will conduct a clinical trial comparing the starting of allopurinol in an acute attack with a two week delay to see if there are any differences in pain, likelihood of staying on allopurinol and getting to their recommended blood urate levels. Once achieved acute attacks of gout are extremely unlikely and patients will no longer need to have pain and loss of work. Our study is one of the top priorities of the EULAR group (European Union League against Rheumatism). A randomised controlled trial is the best way to evaluate an intervention and this will be the first trial to be started in the world.
Trial website
www.gouthappyfeet.com
Trial related presentations / publications
none yet
Public notes

Contacts
Principal investigator
Name 34766 0
Address 34766 0
Country 34766 0
Phone 34766 0
Fax 34766 0
Email 34766 0
Contact person for public queries
Name 18013 0
Bruce Arroll
Address 18013 0
Department of General Practice
and Primary Health Care
The University of Auckland
Private Bag 92019
Auckland 1142
Country 18013 0
New Zealand
Phone 18013 0
+ 64 9 3737599 ext 86978
Fax 18013 0
+ 64 9 373 7624
Email 18013 0
[email protected]
Contact person for scientific queries
Name 8941 0
Bruce Arroll
Address 8941 0
Department of General Practice
and Primary Health Care
The University of Auckland
Private Bag 92019
Auckland 1142
Country 8941 0
New Zealand
Phone 8941 0
+ 64 9 3737599 ext 86978
Fax 8941 0
+ 64 9 373 7624
Email 8941 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.