Safety and efficacy of high dose allopurinol in the management of gout: a randomised interventional study
Phase 4
Completed
- Conditions
- GoutInflammatory and Immune System - Other inflammatory or immune system disordersMusculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12611000845932
- Lead Sponsor
- isa Stamp
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in serum urate from baseline[12 and 24 months];occurrence of allopurinol related adverse effects<br>Adverse effects include abnormal liver function tests and rash. Standardised questions related to adverse events and blood test will be undertaken to detect adverse events. All adverse events will be recorded using CTCAE codes[12 and 24 months]
- Secondary Outcome Measures
Name Time Method number of gouty attacks as reported by the patient[12 and 24 months];health related quality of life as assessed by Health Assessment Questionnaire (HAQ)[12 and 24 months];plasma oxypurinol concentrations[12 and 24 months];Tophus size as mesured by vernier callipers and digital photography[12 and 24 months];urate burden or bone erosion in patients with gout using plain radiographs of the hands and feet, DEXA scan and CT scans of the feet taken at baseline and on an annual basis. These images will be scored according to protocols we have validated[12 and 24 months]