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Comparison of the efficacy of fenofibrate combined with febustat and benzbromarone in the treatment of gout with hypertriglyceridemia

Comparison of the efficacy of fenofibrate combined with febustat and benzbromarone in the treatment of gout with hypertriglyceridemia(Single-center randomized double-blind parallel controlled clinical trial)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018160
Enrollment
Unknown
Registered
2018-09-02
Start date
2018-09-10
Completion date
Unknown
Last updated
2018-09-03

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

Conditions

gout

Interventions

Group 1:Febuxostat + fenofibrate: febuxostat 20mg / day + fenofibrate capsule 200mg /day, oral,at breakfast
Group 2:Benzobromide tablets + fenofibrate: benzbromarone 25mg /day + fenofibrate capsules 200mg / day, oral,at breakfast

Sponsors

Affiliated Hospital of Qingdao University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18 to 75 years old male or female; 2) According to the diagnostic criteria for primary gout (2015 ACR/EULAR standard), 420µmol/L sputum uric acid =540µmol/L; 3) triglyceride =2.3mmol/L or triglyceride = 1.92mmol/L after strict diet control; 4) Voluntarily participate in and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Those who are allergic to the medication or ingredients in this test, are contraindicated, or have allergies to the disease, high-sensitivity constitution; 2) The author of acute gouty arthritis within 2 weeks prior to randomization; 3) Use uric acid lowering drugs within 2 weeks before randomization; 4) Use or plan to use glucocorticoids, anti-tuberculosis drugs (such as ethambutol, pyrazinamide), anticoagulants (such as warfarin or other coumarins) after randomization within 2 weeks prior to randomization Agent, bivalirudin), immunosuppressant (eg cyclosporin, tacrolimus), aspirin or other salicylic acid, azathioprine, 6-mercaptopurine, cyclophosphamide, sulfamethoxazole , trimethoprim, theophylline, niacin, estrogen and other drugs that affect uric acid metabolism; 5) patients with active peptic ulcer, thyroid dysfunction, malignant tumor, active tuberculosis, and urinary calculi; 6) Arthritis caused by rheumatoid arthritis, rheumatoid arthritis, other rheumatic immune diseases, or osteoarthritis requiring analgesics; 7) Heart failure with limited mobility (previous diagnosis, clinical manifestations of heart failure, diagnosis after cardiology consultation), unstable angina pectoris, history of myocardial infarction or other severe heart disease in the past 12 months; 8) Patients with secondary hyperuricemia caused by blood diseases, malignant tumors, kidney diseases or tumor radiotherapy and chemotherapy; 9) Patients with severe renal insufficiency (GFR 1.5 times ULN or TBIL = 1.5 times ULN]; 11) Patients with severe hypertension (systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg) who are not effectively controlled after treatment; 12) Patients who are receiving hypoglycemic drugs or who do not receive hypoglycemic drugs but have HbA1c > 8%; 13) White blood cell count <3.5 x 109 /L, or platelets <100 x 109 /L, or hemoglobin <90g/L; 14) Brain diseases, abnormal judgment ability, and mental illness cannot cooperate; 15) History of alcohol abuse or illicit drugs; 16) pregnant women, lactating women or preparing for pregnancy (including male subjects); 17) Those who have participated in other clinical trials within the first three months of screening; 18) Other investigators consider it inappropriate to participate in the trial.

Design outcomes

Primary

MeasureTime frame
serum uric acid;

Secondary

MeasureTime frame
fraction excretion of uric acid;Triglyceride;Urine PH;eGFR, Estimated Glomerular Filtration Rate;AST, ALT;

Countries

China

Contacts

Public ContactChanggui Li

Affiliated Hospital of Qingdao University

changguili@vip.163.com+86 18661808082

Outcome results

None listed

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