Gout
Conditions
Brief 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.
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.
Interventions
DRUGcolchicine
The drugs used throughout the treatment and control groups. In this design, it is part of the background treatment or the standard treatment.
DRUGetoricoxib
The drugs used by the treatment group and the control group in the first week. It is also part of the background treatment.
DRUGDotinurad
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.
Sponsors
First Affiliated Hospital of Wenzhou Medical University
The Affiliated People's Hospital of Ningbo University
Wenzhou Central Hospital
Yuyao People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the days to resolution from enrolment to the resolution of an acute gout flare between the two groups | From enrollment to the end of treatment at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the main joint visual analogue scale (VAS) scores of the two groups on the 1, 3, 7 and 14 days. | From enrollment to the end of treatment at 1，3，7，14days | The VAS scores range is from 1 to 10. The higher the score, the more severe the pain. |
| Compare the proportions of gout flares at 28 days between two groups | 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 | 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 | 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 | 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 | From enrollment to the end of treatment at 7，14days | — |
Outcome results
None listed