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Trial registered on ANZCTR
Registration number
ACTRN12612000987864
Ethics application status
Approved
Date submitted
10/09/2012
Date registered
13/09/2012
Date last updated
19/07/2019
Date data sharing statement initially provided
19/07/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Gout Treatment. Combined vs Allopurinol alone.
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Scientific title
The effect of Probenecid-Allopurinol combined therapy compared to higher dose Allopurinol on serum uric acid levels in poorly controlled gout patients: A Pilot Prospective Study.
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Secondary ID [1]
281194
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Nil known
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Universal Trial Number (UTN)
U1111-1134-4574
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gout
287375
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Condition category
Condition code
Musculoskeletal
287708
287708
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0
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Other muscular and skeletal disorders
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Inflammatory and Immune System
287724
287724
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The first group will have probenecid added into their usual daily allopurinol dose. (both agents licensed and frequently used in rheumatological practice). For the first 2 weeks, patients will receive low dose probenecid (500mg/24hrs) and allopurinol (300mg/24hrs) and these are increased after two weeks if well tolerated to 1000mg/24hrs probenecid plus the allopurinol (300mg) for the remaining 4weeks of the 6week trial. Both are oral tablets.
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Intervention code [1]
285658
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Treatment: Drugs
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Comparator / control treatment
Second group will have their usual daily dose of allopurinol (300mg) increased. For the first 2 weeks patients will receive allopurinol 400mg once a day and if well tolerated this is increased to 600mg once a day (oral tablets) for the rest of the 6-week period.
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Control group
Active
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Outcomes
Primary outcome [1]
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Comparison of serum uric acid levels
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Assessment method [1]
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Timepoint [1]
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6 weeks
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Secondary outcome [1]
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Frequency of gout attacks, measured by self-reported episodes in a 'flare-diary'
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Assessment method [1]
299115
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Timepoint [1]
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6 weeks
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Secondary outcome [2]
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Patient-reported tolerance including other serious adverse events (death, life-threatening events, hospitalisation or event requiring medical intervention, disability causing significant persistent or permanent impairment, or disruption in daily functioning or quality of life as assessed by the patient's global health assessment)
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Assessment method [2]
299116
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Timepoint [2]
299116
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2, 4, and 6 weeks
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Secondary outcome [3]
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Renal function at the end of the 6week period, and if there has been a deterioration from pre-trial renal function (Comparison of pre-trial eGFR with end-of trial eGFR).
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Assessment method [3]
299117
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Timepoint [3]
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3 and 6 weeks
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Eligibility
Key inclusion criteria
- Gout defined as per the American College of Rheumatology preliminary criteria. Any patient meeting this definition, either from a primary or secondary care source.
- Already receiving long-term maintenance therapy of allopurinol 300mg once a day for more than 1 month, yet still having uncontrolled SUA levels (defined as SUA>0.36).
- Consents to alteration in medications/doses
- Is able to take medications that are not confined to ‘blister packs’ – (pre-formed packs from pharmacist).
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Minimum age
18
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Known hypersensitivity to Probenecid, or higher dose Allopurinol
- Estimated glomerular filtration rate (eGFR) >60ml/min
- Known renal/ureteric stones
- Gout flare less than 2 weeks prior to entering the trial.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. Participants will be enrolled form rheumatology lists, GP lists, and local adverts.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised randomisation once the full number of participants have been obtained.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
No data analysis planned
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Other reasons/comments
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Other reasons
Trial no longer clinically relevant due to changing landscape of medication for gout
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Date of first participant enrolment
Anticipated
1/12/2012
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Actual
3/12/2012
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Date of last participant enrolment
Anticipated
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Actual
28/02/2013
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Date of last data collection
Anticipated
28/02/2013
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Actual
28/02/2013
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Sample size
Target
30
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Accrual to date
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Final
1
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Recruitment outside Australia
Country [1]
4540
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New Zealand
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State/province [1]
4540
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Bay of Plenty
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Funding & Sponsors
Funding source category [1]
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Hospital
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Name [1]
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Tauranga Hospital
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Address [1]
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Tauranga hospital, Cameron Road, Tauranga 3110, Bay of Plenty
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Country [1]
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New Zealand
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Primary sponsor type
Hospital
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Name
Tauranga Hospital
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Address
Tauranga hospital, Cameron Road, Tauranga 3110, Bay of Plenty
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
284796
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Country [1]
284796
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288009
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health and disability ethics committees
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Ethics committee address [1]
288009
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Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145
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Ethics committee country [1]
288009
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New Zealand
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Date submitted for ethics approval [1]
288009
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12/09/2012
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Approval date [1]
288009
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01/12/2012
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Ethics approval number [1]
288009
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Summary
Brief summary
We want to see which type of medication regime would best help patients with poorly controlled gout. One option is to increase the dose of their normal medication (Allopurinol 300mg) or to add in a second drug (Probenecid), with the aim being to compare the reduction in the level of uric acid (i.e. good response is where uric acid levels fall below 0.36, and this correlates well with better gout control), plus which regime is better tolerated by the patient. It is unblinded, therefore the participants will know which regime they are taking. They are assigned into the group taking Allopurinol 600mg (high dose-one drug group) or those taking 300mg with Probenecid (combined drug group). Patients will be followed up for 6weeks, with uric acid levels performed before, and after this 6week period.
Hypothesis:
- We hypothesise that higher doses of Allopurinol will more effectively control chronic gout (measured for this study as obtaining lower serum urate levels, but for patients this means fewer gout 'flares') compared to their pre-trial dose of Allopurinol (300mg).
- Our second hypothesis is that higher dose Allopurinol will be as well tolerated by individuals as their pre-trial dose of 300mg, with no significant deterioration in their kidney function.
- Thirdly, those regimes using a higher dose of Allopurinol will not be inferior to the addition of another agent, in this case Probenecid.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Dr Christine Fox
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Address
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Tauranga Hospital, Cameron Road, Tauranga 3110, Bay of Plenty
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Country
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New Zealand
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Phone
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(+64) 07 579 8000
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Fax
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(+64) 07 578 2649
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Tim Sole
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Address
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Tauranga Hospital, Cameron Road, Tauranga 3110, Bay of Plenty
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Country
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New Zealand
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Phone
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(+64) 07 579 8000
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Fax
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(+64) 07 578 2649
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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No/undecided IPD sharing reason/comment
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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.
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