GoutPhase 4NCT07661030
The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time
A Phase 4 study testing Dotinurad, colchicine and etoricoxib in people with Gout, run by First Affiliated Hospital of Wenzhou Medical University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gout
- What is being tested?
- Dotinurad, colchicine and etoricoxib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2026to 30 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
About this study
Official title: The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time: A Multicenter, Randomized, Parallel-Controlled Study
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.
Read the detailed description
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.
- Conditions
- Gout
- Being tested
- Dotinurad, colchicine, etoricoxib
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DotinuradDrug
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.
colchicineDrug
The drugs used throughout the treatment and control groups. In this design, it is part of the background treatment or the standard treatment.
etoricoxibDrug
The drugs used by the treatment group and the control group in the first week. It is also part of the background treatment.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | 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. Receives: Drug: Dotinurad; Drug: colchicine; Drug: etoricoxib |
| Control group | Experimental | 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. Receives: Drug: Dotinurad; Drug: colchicine; Drug: etoricoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the days to resolution from enrolment to the resolution of an acute gout flare between the two groups
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (6)
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.
Measured: From enrollment to the end of treatment at 1，3，7，14days
Compare the proportions of gout flares at 28 days between two groups
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From enrollment to the end of treatment at 7，14days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated People's Hospital of Ningbo University, Wenzhou Central Hospital, Yuyao People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661030
- Sponsor's protocol ID
- KY2026-011-01
- Status last verified
- Jun 2026
- First submitted
- 14 Sep 2025
- Last updated
- 22 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time: A Multicenter, Randomized, Parallel-Controlled Study
- ClinicalTrials.gov ID
- NCT07661030
- Acronym / sponsor ID
- KY2026-011-01
- Conditions
- Gout
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Collaborators
- The Affiliated People's Hospital of Ningbo University, Wenzhou Central Hospital, Yuyao People's Hospital
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Dotinurad, Drug: colchicine, Drug: etoricoxibThe 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. |
| Control group | Experimental | Drug: Dotinurad, Drug: colchicine, Drug: etoricoxibThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DotinuradThe 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. | Drug | Control group, treatment group |
| colchicineThe drugs used throughout the treatment and control groups. In this design, it is part of the background treatment or the standard treatment. | Drug | Control group, treatment group |
| etoricoxibThe drugs used by the treatment group and the control group in the first week. It is also part of the background treatment. | Drug | Control group, treatment group |
Primary outcome
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
6 secondary outcomes
Compare the main joint visual analogue scale (VAS) scores of the two groups on the 1, 3, 7 and 14 days.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dotinurad, colchicine and etoricoxib in people with Gout, run by First Affiliated Hospital of Wenzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.