Skip to content

Comparative trial on effectiveness and safety of benzbromarone and febuxostat in lower-urate therapy of gout patients with combined types

Comparative trial on effectiveness and safety of benzbromarone and febuxostat in lower-urate therapy of gout patients with combined types

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055197
Enrollment
Unknown
Registered
2022-01-02
Start date
2022-10-31
Completion date
Unknown
Last updated
2023-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gout

Interventions

febuxostat:Febuxostat 25mg qd + citrate mixture 3.5g bid (initial treatment)
Febuxostat 40mg qd + citrate mixture 3.5g bid(adjusted based on urate level)
combination therapy group:Febuxostat 25mg qd + citrate mixture 3.5g bid (initial treatment)
Febuxostat 40mg qd +benzbromarone 25mg qd + citrate mixture 3.5g bid(adjusted based on urate level)

Sponsors

Affiliated hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Men aged 18-70 years; 2. Conform to the diagnostic criteria of primary gout, 7.0 mg/dL (420 micromol/L) 600mg/day/1.73m^2; 4. The patients who did not attack acute gouty arthritis in the first 2 weeks and the elution period were selected; 5. Patients who voluntarily participate in and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergic to all drugs, foods or their ingredients, or allergic to symptoms or allergic constitution; 2. In patients with active liver disease or cirrhosis, or with abnormal liver function, serum alanine aminotransferase (ALT) and glutamic oxaloacetic aminotransferase (AST) exceeded the upper limit of normal range by 1.5 times; 3. Patients with active gastrointestinal ulcer; 4. Thyroid dysfunction; 5. Glomerular filtration rate was <60ml/min; 6. SeverPe heart disease patients, such as: decompensated heart failure (NYHA stage III and IV); unstable angina pectoris; past 12 months with a history of myocardial infarction; 7. Kidney stones, renal cysts, sponge kidney or other obstructive nephropathy; 8. Patients with xanthine inuresis; 9. Rheumatoid arthritis and other causes of joint disease requiring treatment; 10. Azathioprine, 6-mercaptopurine, cyclosporine, cyclophosphamide, bizinamide, sulfamethoxazole, trimethoprim, theophylline, thiazide diuretics, aspirin (more than 325mg/day) or other salicylic acid substances, losartan, intravenous colchicine treatment; 11. Patients with secondary hyperuricemia caused by hematological diseases, renal diseases or tumor radiotherapy and chemotherapy; 12. Brain disease, abnormal judgement; mental illness can not cooperate; 13. Alcoholics or drug addicts; 14. During the first three months of the study, other clinical trials were included; 15. Malignant tumor and active tuberculosis; 16. Concurrent with other diseases, and the researchers believe that the effect of evaluation or compliance is poor; 17. Those taking corticosteroids; 18. White blood cell count < 4 x 10^9/L, or platelets < 100 x 10^9/L, or hemoglobin 90g/L; 19. For any other reason, the researchers consider it inappropriate to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Serum urate;

Secondary

MeasureTime frame
Blood biochemistry;Kidney Ultrasound;The frequency of acute gout;glycoprotein antigen72-4 (CA72-4);C reactive protein (CRP);glycoprotein antigen72-4 (CA72-4);Urine routine;Urine PH;Joint ultrasound;Glomerular filtration rate (eGFR);Joint X-ray;fractional excretion of urate (FEUA);uric acid excretion (UUE);Erythrocyte sedimentationrate (ESR);

Countries

China

Contacts

Public ContactChanggui Li

Affiliated Hospital of Qingdao University

changguili@vip.163.com+86 16678637856

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026