A Phase 4 interventional study of Febuxostat in Gout and Uric Acid, sponsored by Seoul National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years to 79 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment
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.
1. Background
2. Sample size determination
2. General principles of statistical analysis
1) Categorical variables will be presented as frequencies and percentages, with 95% CIs if needed. Chi-square tests and Fisher's exact tests will be used for categorical outcomes. For missing data or withdrawals, the analysis will use available data, replacing missing values with the previous measurement.
2) Analysis population
3) Efficacy analysis The primary analysis population is the PPS, with sensitivity analysis conducted in the FAS.
4) Safety analysis The primary analysis population is the SAS. Descriptive statistics will be presented and analyzed for all adverse events occurring after the administration of the investigational drug, as well as for clinical laboratory results, vital signs, physical examinations, electrocardiograms, and liver function tests.
345 studies on the registry are indexed under Gout; 49 are open to participants now.
This study's planned enrollment of 59 is below the median of 83 across 286 interventional studies indexed under Gout.
Browse Gout studies →Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adult gout patients aged ≥19 but \<80 years.
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
Subjects who continuously require prophylactic low-dose colchicine/NSAIDs.
Subjects classified as having high-risk alcohol use according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA):
For men \<65 years: more than 14 drinks per week or for men ≥65 years or women: more than 7 drinks per week
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The participants (n=15) will take a placebo once daily for 6 months, followed by febuxostat 20 mg once daily for the next 6 months. Randomization is stratified based on the urinary urate excretion rate (≤5.5% vs. \>5.5%).
Drug: Febuxostat
The participants (n=29) will take febuxostat 20 mg once daily for 12 months. Randomization is stratified based on the urinary urate excretion rate (≤5.5% vs. \>5.5%).
Drug: Febuxostat
To serve as an observational reference group, The participants (n=15) will continue their urate-lowering agents for 12 months. Randomization is stratified based on the urinary urate excretion rate (≤5.5% vs. \>5.5%).
The minimal approved dose of febuxostat is 40 mg/day. We will use 0.5 tablet of febuxostat 40 mg or its placebo.
Also known as: Usoric® Tab 40mg
The proportion of patients with serum urate levels <7.0 mg/dL
The proportion of patients who maintain serum urate levels \<7.0 mg/dL at 6 months after taking febuxostat 20 mg once daily or after suspending urate-lowering agents
Time frame: 6 months
The proportion of subjects with serum urate <7.0 mg/dL
We will compare among maintaining, reducing, and discontinuing groups at 6 months and between maintaining and reducing groups at 12 months
Time frame: 6 months and 12 months
Serum urate levels
We will compare among maintaining, reducing, and discontinuing groups at 6 months and between maintaining and reducing groups at 12 months
Time frame: 6 months and 12 months
Gout Impact Scale (GIS) score using the Korean version
We will compare among maintaining, reducing, and discontinuing groups at 6 months and between maintaining and reducing groups at 12 months
Time frame: 6 months and 12 months
Patient's overall assessment of gout using a visual analog scale
We will compare among maintaining, reducing, and discontinuing groups at 6 months and between maintaining and reducing groups at 12 months
Time frame: 6 months and 12 months
EuroQol(EQ)-5D score
We will compare among maintaining, reducing, and discontinuing groups at 6 months and between maintaining and reducing groups at 12 months
Time frame: 6 months and 12 months
Gout activity score (GAS)
GAS is calculated as (0.09 × last 12-month attacks) + \[1.01 × square root (serum uric acid)\] + \[0.34 × VAS patient\] + \[0.53 × ln (1 + tophi number)\] We will compare among maintaining, reducing, and discontinuing groups at 6 months and between maintaining and reducing groups at 12 months.
Time frame: 6 months and 12 months
Drug adherence
Adherence is defined as defined as taking 80% or more of the prescribed medication (using by the number of remaining pills). We will compare among maintaining, reducing, and discontinuing groups at 6 months and between maintaining and reducing groups at 12 months.
Time frame: 6 months and 12 months
Incidence rate of acute gouty arthritis
We will compare among maintaining, reducing, and discontinuing groups at 6 months and between maintaining and reducing groups at 12 months.
Time frame: 6 months and 12 months
Swollen and tender joint counts of 66/68 joints
We will compare among maintaining, reducing, and discontinuing groups at 6 months and between maintaining and reducing groups at 12 months.
Time frame: 6 months and 12 months
The reliability of the ultrasound scoring system for tophi in gout patients
We will compare the USG scores evaluated by each institution with ones evaluated by an independent review committee.
Time frame: Baseline
Plan to share: No
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