A Phase 4 interventional study of Dotinurad and colchicine in Gout, sponsored by First Affiliated Hospital of Wenzhou Medical University. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by First Affiliated Hospital of Wenzhou Medical University · Phase 4, Interventional, and Treatment
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.
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. At the same time, to compare whether there are differences in the uric acid-lowering effects of initiating Dotinurad treatment at different times.And to evaluate the safety and tolerability of the treatment regimen.
345 studies on the registry are indexed under Gout; 49 are open to participants now.
This study's planned enrollment of 142 is above the median of 83 across 286 interventional studies indexed under Gout.
Browse Gout studies →First Affiliated Hospital of Wenzhou Medical University is the lead sponsor of 83 studies on the registry; 57 are open to participants now.
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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.
Exclusion Criteria:
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.
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.
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.
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.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
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.
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.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The treatment group will be administered dotinurad 2 mg/day, colchicine 1 mg/day, and etoricoxib 120 mg/day (for 1-3 days) or 60 mg/day(for 4-7 days) for a duration of 4 weeks.
Drug: Dotinurad · Drug: colchicine · Drug: etoricoxib
The control group will be administered colchicine 1 mg/day, and etoricoxib 120 mg/day (for 1-3 days) or 60 mg/day(for 4-7 days) for 2 weeks. Then the control group will be administered dotinurad 2mg/day, colchicine 1 mg/day for 2 weeks.
Drug: Dotinurad · Drug: colchicine · Drug: etoricoxib
The drug used in the treatment group (from week 1 to 4)and the control group (from week 3 to 4). This is the main intervention factor of the study.
The drugs used throughout the treatment and control groups. In this design, it is part of the background treatment or the standard treatment.
The drugs used by the treatment group and the control group in the first week. It is also part of the background treatment.
Compare the days to resolution from enrolment to the resolution of an acute gout flare between the two groups
Time frame: From enrollment to the end of treatment at 12 weeks
Compare the main joint visual analogue scale (VAS) scores of the two groups on the 1, 3, 7 and 14 days.
The VAS scores range is from 1 to 10. The higher the score, the more severe the pain.
Time frame: From enrollment to the end of treatment at 1，3，7，14days
Compare the proportions of gout flares at 28 days between two groups
Time frame: From enrollment to the end of treatment at 28 days
Compare the proportions of subjects whose serum uric acid (SUA) levels were ≤ 360 umol/L at 7, 14 and 28 days between two groups
Time frame: From enrollment to the end of treatment at 7, 14 and 28 days
Compare the percentage reduction in SUA from the baseline at 7, 14 and 28 days between two groups
Time frame: From enrollment to the end of treatment at 7, 14 and 28 days
Compare the C-reactive protein (CRP) levels of the two groups at 7 and 14 days
Time frame: From enrollment to the end of treatment at 7，14days
Compare the erythrocyte sedimentation rate (ESR) levels of the two groups at 7 and 14 days
Time frame: From enrollment to the end of treatment at 7，14days
No study locations are listed for this record.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dotinurad
First Affiliated Hospital of Wenzhou Medical University