A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients (EPIC)
Gout
About this trial
This is an interventional treatment trial for Gout
Eligibility Criteria
Inclusion Criteria: for screening ≥19 to ≤75 years of age at the time of written informed consent Diagnosed record with gout, or ACR/EULAR 2015 score ≥8 Able and willing to actively participate in TLC programme Signed ICF for voluntary study participation for randomization sUA level ≥7.0 mg/dL ACR/EULAR 2015 score ≥8 Exclusion Criteria: Medical history Malignant tumor, Urolithiasis within 5 years, Hypersensitivity disease, Lesch-Nyhan syndrome, Hereditary problems, Ischemic heart disease, Prior or planned organ transplant recipient. Concurrent disease or laboratory test abnormality Uncontrolled diabetes mellitus, Uncontrolled hypertension, Uncontrolled dyslipidemia, AST or ALT ≥2×ULN, total bilirubin ≥1.5×ULN, eGFR <30 mL/min/1.73m^2, Uncontrolled thyroid dysfunction, HIV, HBV or HCV positive, Drug and alcohol abuse, BMI ≥40 kg/m^2 History of gout flare between 2 weeks before written informed consent and immediately before randomization Any cardiovascular abnormalities that might affect the study Prior or planned treatment with xanthine oxidase inhibitors, uricosuric agents, or uricolytic agents Prior or planned treatment with drugs acting on human uric acid transporter 1 or diuretics Prior or planned treatment with intravenous and oral high dose systemic corticosteroids, mercaptopurine, azathioprine, or theophylline Hypersensitivity to the IP (epaminurad or febuxostat) Pregnant or lactating woman.
Sites / Locations
- Inha University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Active Comparator
Active Comparator
Epaminurad 6 mg
Epaminurad 9 mg
Febuxostat 40 mg
Febuxostat 80 mg
[Main study period] Epaminurad 6 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
[Main study period] Epaminurad 9 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
[Main study period] Febuxostat 40 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.
[Main study period] Febuxostat 80 mg and three matched placebos for 20 weeks. [Extension study period] Epaminurad 6 mg or 9 mg (open label) for 28 weeks.