Gout Treatment. Combined vs Allopurinol alone.
Phase 4
- Conditions
- GoutMusculoskeletal - Other muscular and skeletal disordersInflammatory and Immune System - Other inflammatory or immune system disorders
- Registration Number
- ACTRN12612000987864
- Lead Sponsor
- Tauranga Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 30
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of serum uric acid levels[6 weeks]
- Secondary Outcome Measures
Name Time Method Frequency of gout attacks, measured by self-reported episodes in a 'flare-diary'[6 weeks];Renal function at the end of the 6week period, and if there has been a deterioration from pre-trial renal function (Comparison of pre-trial eGFR with end-of trial eGFR).[3 and 6 weeks];Patient-reported tolerance including other serious adverse events (death, life-threatening events, hospitalisation or event requiring medical intervention, disability causing significant persistent or permanent impairment, or disruption in daily functioning or quality of life as assessed by the patient's global health assessment)[2, 4, and 6 weeks]