CompletedPhase 4ACTRN12611000845932

Safety and efficacy of high dose allopurinol in the management of gout: a randomised interventional study

Sponsor

Lisa Stamp

Enrollment

200 participants

Start Date

Feb 7, 2012

Study Type

Interventional

Conditions

Gout

Summary

Gout is common in New Zealand, particularly in Maori and Pacific people. It is an extremely painful form of arthritis caused by uric acid crystals within joints. Repeated gout attacks cause joint damage. To prevent gout attacks, blood urate levels must be lowered to <0.36mmol/L. The most commonly used medication is allopurinol, which inhibits the production of urate. Current recommendations for allopurinol dose are based on kidney function. There is ample evidence that many patients fail to achieve adequate reduction in urate levels with the recommended dose. We have preliminary evidence that increasing the dose above recommended dose is safe and effective. We wish to undertake a clinical trial to confirm our preliminary findings, especially with respect to the safety of this approach. This study has the potential to provide a significant change in clinical practice and improve control of gout, thereby preventing joint damage and disability.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study evaluates whether high-dose allopurinol is safe and effective for managing gout. It enrolls adults aged 18+ who have gout according to standard medical criteria, are already on at least a baseline dose of allopurinol for at least one month, and still have elevated uric acid levels.

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 is a randomised open interventional clinical trial. Patients with gout and serum urate greater than or equal to 0.36mmol/L receiving at least the creatinine clearance (CrCL)-based allopurinol dose will be recruited. Patient will be randomised to either continue the current standard of care CrCL-based dose of allopurinol (controls) or undergo allopurinol dose escalation. At 12 months control patients on the CrCL-based allopurinol dose with SU>0.36mmol/L will enter the dose escalation arm of the study (pending an interim safety analysis). All patients will have three-monthly study visits. Allopurinol dose escalation protocol: There will be 2 phases; Phase 1: Achieving the target SU and Phase 2: Maintaining target SU. In Phase 1, allopurinol will be increased by 50-100mg every month until the target SU <0.36mmol/l is achieved. In addition to the study visits every three months, a monthly blood test will be taken and follow-up phone call to assess side effects in the intervening months. These monthly blood tests will continue until patients have achieved three consecutive monthly visits with a SU <0.36mmol/L. At this point Phase 2 will commence and patients will be seen three monthly until they have completed 24 months from baseline. If the serum urate increases above target in phase 2 the allopurinol dose may be increased Allopurinol will be taken daily by oral tablet