Timing matters: study tests if starting gout drug during a flare is safe
NCT ID NCT07661030
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares starting dotinurad, a urate-lowering drug, during an acute gout flare versus waiting until the flare resolves. About 142 adults with gout will be randomly assigned to one of two timing schedules. Researchers will measure how quickly the flare resolves and whether starting early increases pain or inflammation.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dotinurad
- What this could lead to
- If successful, this could show that starting urate-lowering therapy during a gout flare is safe and does not worsen pain or inflammation, allowing earlier treatment.
- What could go wrong
- This is a phase 4 trial with a moderate number of participants. It may not prove long-term benefits, and some patients might experience increased pain or flare recurrence.
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 142 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 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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18 to 70 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: * Male or female individuals aged 18-70 years old. * Meet the 2015 ACR/EULAR diagnostic criteria of gout. * With an onset of acute gout flares within 7 days. * With gout experiencing gout flares ≥2 times; or with gout experiencing gout flares 1 time and is younger than 40 years old; or with gout experiencing gout flares 1 time and has a serum uric acid level greater than 480 μmol/L and/or has co-morbidities (renal function impairment, hypertension,). * Provide a signed written informed consent form. Exclusion Criteria: * Has secondary hyperuricemia. * Serum uric acid level \< 360 μmol/L. * Used IL-1β inhibitors within 6 months before screening. * Used uric acid-lowering drugs within 1 month before screening. * Used anti-inflammatory drugs within 14 days before screening. * Comorbidities with nephrolithiasis or clinical urinary calculi * History of kidney transplantation or dialysis. * Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m². * AST or ALT \> 2 times the upper limit of normal. * Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg during the screening period. * White blood cell count \< 3.5 × 10⁹/L, or platelet count \< 100 × 10⁹/L, or hemoglobin \< 90 g/L. * Currently in the treatment period of malignant tumors, or within 6 months after the end of the treatment period. * Congestive heart failure (New York Heart Association \[NYHA\] cardiac function classification II-IV), confirmed ischemic heart disease, peripheral artery disease and/or cerebrovascular disease (including patients who have recently undergone coronary artery bypass grafting or angioplasty). * Hypersensitivity to the study drugs or their excipients, or all of urine alkalinizer (potassium citrate/sodium citrate hydrate compound preparations). * Have active gastrointestinal ulcers/bleeding, or have had a recurrence of ulcers/bleeding in the past.
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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 official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
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Other studies related to the condition(s) this trial covers.
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