RecruitingPhase 4ACTRN12622001279718

Allopurinol prescribing for gout management in Aotearoa New Zealand

Easing the way to achieving target serum urate in people with gout: a non-inferiority strategy trial using an allopurinol dosing model. (The Easy-Allo study)

Sponsor

University of Otago

Enrollment

380 participants

Start Date

Feb 20, 2023

Study Type

Interventional

Conditions

Gout

Summary

Gout is particularly prevalent in Aotearoa/NZ, with 13.8% of Maori men, 22.5% of Pacific men, and 6.9% of NZ European men affected. Effective management requires lowering the blood urate level to a treatment target, usually with a medication called allopurinol. There are important inequities based on ethnicity in allopurinol prescribing in Aotearoa. The current best practice treatment strategy is time consuming and difficult to implement. An easier way to use allopurinol is required, especially since gout disproportionately affects middle-age men who are frequently working and are not able to take time off work or afford the costs involved with the current strategy. The aim of this Programme is to determine whether a protocol-driven allopurinol dose escalation strategy based on the dose predicted to achieve target urate is as effective as the current best practice intensive treat-to-target strategy.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Gout is a painful form of arthritis caused by a build-up of uric acid crystals in the joints, often triggering sudden, severe attacks of swelling and intense pain — usually in the big toe, ankle, or knee. In New Zealand, gout disproportionately affects Maori and Pacific men, and effective long-term management with a medication called allopurinol (which lowers uric acid levels in the blood) can dramatically reduce attacks and joint damage. However, getting the dose right under current guidelines is a slow, time-consuming process that involves many clinic visits. This study is comparing two allopurinol dosing strategies: the current gold-standard approach (gradually titrating the dose over many visits until a uric acid target is reached), versus a simpler protocol where the predicted effective dose is started more quickly, based on an equation. The goal is to find whether this faster, more streamlined approach is just as effective — which would be particularly valuable for working men with limited time or resources. You may be eligible if you are over 18 years old, have been diagnosed with gout according to international criteria, have an elevated uric acid level, and either are not yet on allopurinol or are on a dose that has not reached the treatment target. People with severe kidney disease, previous allopurinol reactions, or certain genetic risk factors for a serious skin reaction would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Allopurinol dose escalation to a maximum of 900mg will be based on a monthly serum urate and phone contact with the study coordinator. The dose will be increased until serum urate has been <0.36mmol/l for three, monthly consecutive visits. Starting dose of allopurinol will be 50mg daily in those with eGFR<60mls/min and 100mg daily in those with eGFR great than or equal 60mls/min. For all participants allopurinol dose will be increased monthly by 50 or 100mg per day as determined by eGFR. Adherence will be assessed by pill count. Participants will continue allopurinol for the entire 36 months. Allopurinol will be in the form of an oral tablet.