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

Inclusion Criteria4

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

Exclusion Criteria11

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)

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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.