None listed
Conditions
Brief 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.
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
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
Sponsors
Lisa Stamp
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with gout, as defined by the American College of Rheumatology Criteria, receiving at least the CrCL-based dose of allopurinol for at least one month and with a SU greater than or equal to 0.36mmol/L will be recruited.
Exclusion criteria
Patients with a history of intolerance to allopurinol and patients receiving azathioprine
Outcome results
None listed