RecruitingPhase 4ACTRN12612001188820

Safety and efficacy of immediate versus delayed allopurinol treatment for the prevention of gout flares in pacific, maori and other people

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.

Sponsor

Department of General Practice and Primary Health Care, School of Population Health, University of Auckland

Enrollment

200 participants

Start Date

Sep 12, 2012

Study Type

Interventional

Conditions

Gout

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 75 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at the best time to start the gout medication allopurinol. Gout is a painful joint condition caused by too much uric acid in the blood, and allopurinol is a medicine that lowers that acid. Doctors have debated whether to start it during a gout attack or wait two weeks. This trial is one of the first in the world to directly compare those two approaches to find out which leads to better pain control and long-term results. You may be eligible if: - You are between 18 and 75 years old - You speak enough English (or have access to an interpreter) - You have had at least one previous gout attack in the same joint and a doctor has confirmed the diagnosis - Your pain level is greater than 3 out of 10 at the time of enrolment You may NOT be eligible if: - You have insulin-dependent diabetes - You are on dialysis or have severe kidney failure - You have a terminal illness - Your blood pressure is very low (under 100 mmHg systolic) or your heart rate is over 100 - You have taken steroids or colchicine in the past week - You are already taking allopurinol - You have had a skin rash from allopurinol before - You are pregnant or planning to become pregnant in the next few months Talk to your doctor about whether this trial might be right for you.

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

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 ora

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.