Actively Recruiting
the Effects of Febuxostat Dose Tapering in Gout Patients Optimally Controlled for 5 Years or More
Led by Seoul National University Hospital · Updated on 2026-04-29
59
Participants Needed
1
Research Sites
101 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Hospital
Lead Sponsor
G
Gachon University Gil Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 using questionnaires and diaries. Additionally, musculoskeletal ultrasonography and serum sample collection will be performed at baseline to study predictors for maintaining serum urate levels \<7.0 mg/dL after reducing or suspending urate-lowering therapy.
CONDITIONS
Official Title
the Effects of Febuxostat Dose Tapering in Gout Patients Optimally Controlled for 5 Years or More
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 to less than 80 years
- Diagnosis of gout treated with urate-lowering therapy (allopurinol or febuxostat alone or combined) for at least 5 years
- At least five serum urate measurements in the past 5 years with all levels below 6.0 mg/dL or area under the curve less than 33.0 mg/dL x year
- No visible or palpable tophi on 18 joint sites and ears
- No acute gout attack or kidney stones in the past 12 months
- Estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73m² or higher
- Provided written informed consent
You will not qualify if you...
- Continuous requirement for prophylactic low-dose colchicine or NSAIDs
- Use of low-dose urate-lowering agents alone (allopurinol ≤200 mg/day or febuxostat ≤20 mg/day), except combination of low-dose allopurinol and febuxostat
- Use of medications affecting serum uric acid or uric acid excretion (benzbromarone, fenofibrate, loop diuretics, thiazide or thiazide-like diuretics, losartan)
- High-risk alcohol use: men under 65 years drinking more than 14 drinks per week; men 65 or older or women drinking more than 7 drinks per week
- History of hypersensitivity to febuxostat or allopurinol
- Unstable cardiovascular conditions needing urgent therapy adjustment
- Use of mercaptopurine or azathioprine
- Genetic disorders like galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Moderate or severe liver dysfunction (AST or ALT greater than 3 times upper normal limit)
- Anticipated significant risks or poor drug adherence that could affect study participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707
Actively Recruiting
Research Team
Y
Yun Jong Lee, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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