Hyperuricemia is a metabolic disorder syndrome
Conditions
Interventions
Experimental group:Topirast tablets 200 mg/day dose group
Control group:Allopurinol tablet
Sponsors
XIANG'AN HOSPITAL OF XIAMEN UNIVERSITY
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years (inclusive), with no restriction on gender. 2. Patients with clinically diagnosed gout in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Hyperuricemia and Gout (2019) [1-2], and serum uric acid (sUA) >= 480 µmol/L (8.0 mg/dL) at the last screening visit. 3. Body mass index (BMI) between 18 kg/m^2 and 35 kg/m^2 (inclusive). 4. Voluntarily signed informed consent approved by the Ethics Committee prior to study enrollment.
Exclusion criteria
Exclusion criteria: 1. Participants with a history of allergy or contraindications to any component of the investigational product Topiroxostat Tablets, the control drug Allopurinol Tablets or placebo, or those who were previously intolerant to Allopurinol. 2. Participants with secondary hyperuricemia caused by other diseases (e.g., malignancy, severe chronic kidney disease, hematological diseases) or medications. 3. Participants whose interval from the resolution of the latest acute gout flare to randomization was less than 2 weeks. 4. Participants who used other urate-lowering drugs (including but not limited to probenecid, benzbromarone, allopurinol, febuxostat, dotinurad, recombinant uricase, etc.) within 14 days prior to randomization. 5. Participants who received any diuretics within 14 days prior to randomization. 6. Hypertensive patients taking urate-lowering antihypertensive agents such as losartan, amlodipine and felodipine; hyperlipidemic patients taking urate-lowering lipid-regulating agents such as fenofibrate and atorvastatin; diabetic patients taking urate-lowering hypoglycemic agents including alpha-glucosidase inhibitors (e.g., acarbose), insulin sensitizers (e.g., pioglitazone), dipeptidyl peptidase inhibitors (e.g., sitagliptin), metformin and SGLT-2 inhibitors (e.g., empagliflozin), with doses not stabilized for more than 1 month prior to randomization. 7. Participants with positive results for HLA-B*5801 genetic testing. 8. Participants diagnosed with refractory gout. 9. Participants with a documented history of gastrointestinal bleeding, active peptic ulcer or gastrointestinal perforation within the past 6 months; or those suffering from other gastrointestinal diseases such as ulcerative colitis and Crohn's disease, which, in the investigator's opinion, may affect drug disposition or safety evaluation. 10. Participants with uncontrolled hypertension: sitting systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg. 11. Participants with a history of diabetes mellitus and glycated hemoglobin (HbA1c) > 8.0%. 12. Participants with abnormal liver function: alanine transaminase (ALT) and/or aspartate transaminase (AST) > 1.5 times the upper limit of normal (ULN). 13. Participants with impaired renal function: estimated glomerular filtration rate (eGFR) < 30 mL/(min·1.73 m^2). 14. Participants with white blood cell (WBC) count < 3.0 x 10^9/L, and/or hemoglobin (Hb) < 90 g/L, and/or platelet (PLT) count < 80 x 10^9/L. 15. Participants with severe cardiovascular and cerebrovascular diseases, hematological disorders, poorly controlled endocrine diseases (e.g., hyperthyroidism, hypothyroidism), severe respiratory diseases, central nervous system diseases or malignant tumors, which may interfere with the assessment of efficacy endpoints, as determined by the investigator. 16. Participants with psychiatric disorders or intellectual disabilities who are unable to correctly report subjective symptoms or record medication use. 17. Participants who enrolled in any other clinical trial (excluding placebo or non-treatment groups) within 3 months prior to screening, or those planning to participate in other drug clinical trials. 18. Participants with a history of alcohol or drug abuse at screening. Average weekly alcohol intake: more than 21 units for males and more than 14 units for females (1 unit = 360 mL beer, or 150 mL red wine, or 45 mL distilled spirits/liquor). 19. Females or males of reproductive potential (excluding males wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of achieving target serum uric acid = 360 µmol/L (6.0 mg/dL) at Week 24 of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| serum uric acid levels ;Changes from baseline in renal injury markers at Week 24 of treatment;Rate of acute gout flares within 24 weeks of treatment; | — |
Countries
China
Contacts
Public ContactLi changgui
XIANG'AN HOSPITAL OF XIAMEN UNIVERSITY
Outcome results
None listed