None listed
Conditions
Brief summary
We want to see which type of medication regime would best help patients with poorly controlled gout. One option is to increase the dose of their normal medication (Allopurinol 300mg) or to add in a second drug (Probenecid), with the aim being to compare the reduction in the level of uric acid (i.e. good response is where uric acid levels fall below 0.36, and this correlates well with better gout control), plus which regime is better tolerated by the patient. It is unblinded, therefore the participants will know which regime they are taking. They are assigned into the group taking Allopurinol 600mg (high dose-one drug group) or those taking 300mg with Probenecid (combined drug group). Patients will be followed up for 6weeks, with uric acid levels performed before, and after this 6week period. Hypothesis: - We hypothesise that higher doses of Allopurinol will more effectively control chronic gout (measured for this study as obtaining lower serum urate levels, but for patients this means fewer gout 'flares') compared to their pre-trial dose of Allopurinol (300mg). - Our second hypothesis is that higher dose Allopurinol will be as well tolerated by individuals as their pre-trial dose of 300mg, with no significant deterioration in their kidney function. - Thirdly, those regimes using a higher dose of Allopurinol will not be inferior to the addition of another agent, in this case Probenecid.
Interventions
The first group will have probenecid added into their usual daily allopurinol dose. (both agents licensed and frequently used in rheumatological practice). For the first 2 weeks, patients will receive low dose probenecid (500mg/24hrs) and allopurinol (300mg/24hrs) and these are increased after two weeks if well tolerated to 1000mg/24hrs probenecid plus the allopurinol (300mg) for the remaining 4weeks of the 6week trial. Both are oral tablets.
Sponsors
Tauranga Hospital
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 90 Years
Healthy volunteers
No
Inclusion criteria
- Gout defined as per the American College of Rheumatology preliminary criteria. Any patient meeting this definition, either from a primary or secondary care source. - Already receiving long-term maintenance therapy of allopurinol 300mg once a day for more than 1 month, yet still having uncontrolled SUA levels (defined as SUA>0.36). - Consents to alteration in medications/doses - Is able to take medications that are not confined to ‘blister packs’ – (pre-formed packs from pharmacist).
Exclusion criteria
- Known hypersensitivity to Probenecid, or higher dose Allopurinol - Estimated glomerular filtration rate (eGFR) >60ml/min - Known renal/ureteric stones - Gout flare less than 2 weeks prior to entering the trial.
Outcome results
None listed