Gout drug tapering trial: could patients finally take less medicine?
NCT ID NCT06622603
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether people with well-controlled gout (for at least 5 years) can safely reduce or stop their daily febuxostat. Fifty-nine adults will be split into three groups: one that lowers the dose, one that stops for 6 months then restarts a lower dose, and one that stays on their usual treatment. Researchers will track uric acid levels and any symptom return over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- febuxostat
- What this could lead to
- If successful, this could show that some gout patients can safely lower their medication dose without flare-ups, simplifying long-term management.
- What could go wrong
- This is a small, early-phase trial with only 59 participants. Results may not apply to all gout patients, and reducing medication could still cause symptom return or high uric acid levels.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 59 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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 with an estimated glomerular filtration rate (eGFR) of 60 mL/min/1.73m² or higher, based on the Cockcroft-Gault formula. 7. Patients who voluntarily provide written informed consent to participate. * Exclusion Criteria: 1. Subjects who continuously require prophylactic low-dose colchicine/NSAIDs. 2. Subjects already having taken low-dose urate-lowering agents. The low-dose urate-lowering agents are defined as allopurinol ≤200 mg/day or febuxostat ≤20 mg/day. But patients on a combination of low-dose allopurinol and febuxostat are eligible. 3. Subjects taking medications that could affect serum uric acid levels and uric acid fractional excretion rates, such as benzbromarone, fenofibrate, loop diuretics, thiazide or thiazide-like diuretics, and losartan. 4. 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 5. Subjects with a history of hypersensitivity to febuxostat or allopurinol 6. Subjects with unstable cardiovascular conditions, who require adjustment of urgent their therapy 7. Subjects taking mercaptopurine or azathioprine 8. Subjects with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 9. Subjects with moderate or severe liver dysfunction (AST or ALT levels greater than 3 times the upper normal limit) 10. Subjects for whom investigators anticipate that a change in a urate-lowering agent dose could present significant risks or that any factor could severely impact drug adherence, complicating study registration.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Seoul National University Bundang Hospital
RECRUITINGSeongnam-si, Gyeonggi-do, 463-707, South Korea
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