The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare… (NCT07661030) | Clinical Trial Compass
Not Yet RecruitingPhase 4
The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time
142 participantsStarted 2026-07-30
Plain-language summary
To confirm that initiating Dotinurad for uric acid uric acid lowering during the acute phase of gout is non-inferior to initiating it after the acute phase of gout has subsided, and to analyze whether initiating Dotinurad treatment during the acute phase will increase the pain level, the recurrence rate of gout, and the inflammatory level of patients.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, peri…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Compare the days to resolution from enrolment to the resolution of an acute gout flare between the two groups
Timeframe: From enrollment to the end of treatment at 12 weeks
Trial details
NCT IDNCT07661030
SponsorFirst Affiliated Hospital of Wenzhou Medical University