the Effects of Febuxostat Dose Tapering in Gout Patients Optimally Controlled for 5 Years
The goal of this clinical trial is to compare the changes in serum urate levels and symptom recurrence after reducing or suspending urate-lowering agents in well-controlled gout patients (the 'after dishes are clean' state in the Dirty Dish hypothesis) Researchers will compare three randomized groups: the reducing grou
| Condition(s) | Gout, Uric Acid |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | The goal of this clinical trial is to compare the changes in serum urate levels and symptom recurrence after reducing or suspending urate-lowering agents in well-controlled gout patients (the 'after dishes are clean' state in the Dirty Dish hypothesis) Researchers will compare three randomized groups: the reducing group takes febuxostat 20 mg once daily for 12 months, the discontinuing group takes a placebo once daily for 6 months, followed by febuxostat 20 mg once daily for the next 6 months, and the maintaining group continues their pre-study urate-lowering agents for 12 months, serving as an observational reference group. During the 12-month study period, participants will visit every 3 months for laboratory evaluations including serum urate levels, and for checking symptomatic status u |
| Who can participate | * Inclusion Criteria: 1. Adult gout patients aged ≥19 but \<80 years. 2. Gout patients treated with urate-lowering therapy (either allopurinol or febuxostat monotherapy, or a combination of two agents) for at least the past 5 years. 3. Patients who have at least five serum urate level measurements over the past 5 years and meet one of the following criteria: All serum urate levels measured in the past 5 years have been maintained below 6.0 mg/dL; or the area under the curve (AUC) of serum urate levels over time for the past 5 years is less than 33.0 mg/dL x year 4. Patients without palpable or visible tophi on physical examination (evaluated at pre-defined 18 joint sites and the ears). 5. Patients without acute gouty attack or history of nephrolithiasis in the past 12 months 6. Patients wi |
| Ages | 19 Years to 79 Years |
| Sex | All |
| Lead sponsor | Seoul National University Hospital |
| Locations | Seongnam-si, Gyeonggi-do, South Korea |
| Start date | 2025-09-10 |
| NCT ID | NCT06622603 |
| Official listing | https://clinicaltrials.gov/study/NCT06622603 |