Phase
Condition
Gout (Hyperuricemia)
Treatment
D-0120
Benzbromarone
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject voluntarily takes part in the study after being fully informed,signs awritten ICF, and agrees to follow procedures specified in the study protocol;
Subject who meets one of the following criteria: i. History of gout attack: Meeting 2015 ACR/EULAR Gout Classification Criteria andfasting serum uric acid ≥ 480 μmol/L at screening (local laboratory of study site)ii. For asymptomatic hyperuricemia, it is acceptable to meet either of the twocriteria:
Serum uric acid ≥ 420 μmol/L for at least 3 months (subject to hospital medicalrecord or test report), diagnosis with hyperuricemia before screening, andfasting serum uric acid at screening ≥ 540 μmol/L (local laboratory of studysite);
Serum uric acid ≥ 420 μmol/L for at least 3 months (subject to hospital medicalrecord or test report), diagnosis with hyperuricemia before screening, andfasting serum uric acid at screening ≥ 480 μmol/L (local laboratory of studysite), with concomitant primary hypertension or primary hyperlipidemia or type 2 diabetes mellitus, which is treated with a stable dose of antihypertensive orlipid-lowering or hypoglycemic treatment for at least 3 months;
At screening, 18.0 kg/m2 ≤ body mass index (BMI) ≤ 32.0 kg/m2;
Hematology, Blood chemistry and Urinalysis examination were basically normal.
Exclusion
Exclusion Criteria:
Prior intolerance to benzbromarone or contraindication to medication;
Secondary hyperuricemia caused by tumor, chronic kidney disease, blood disease ordrugs, etc.;
Arthropathy caused by arthritis rheumatoid, purulent arthritis, traumatic arthritis,psoriatic arthritis, pseudogout or systemic lupus erythematosus, etc.;
Arthropathy caused by chemotherapy, radiotherapy or chronic lead poisoning;
Urinary calculi confirmed by B-ultrasound during screening period;
Study Design
Connect with a study center
Inner Mongolia Baogang Hospital
Baotou,
ChinaSite Not Available
Beijing Chao-yang Hospital, Capital Medical University
Beijing,
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing,
ChinaSite Not Available
The First Hospital of Jilin University
Changchun,
ChinaSite Not Available
The First People's Hospital of Changzhou
Changzhou,
ChinaSite Not Available
Foshan Nanhai People's Hospital
Foshan,
ChinaSite Not Available
Guangzhou First People's Hospital
Guangzhou,
ChinaSite Not Available
Nanfang Hospital
Guangzhou,
ChinaSite Not Available
The Second People's Hospital of Guangdong Province
Guangzhou,
ChinaSite Not Available
Zhujiang Hospital of Southern Medical University
Guangzhou,
ChinaSite Not Available
The First Affiliated Hospital of Hainan Medical College
Haikou,
ChinaSite Not Available
The First Affiliated Hospital Of University Of South China
Hengyang,
ChinaSite Not Available
Huzhou Third People's Hospital
Huzhou,
ChinaSite Not Available
First Affiliated Hospital of Kunming Medical University
Kunming,
ChinaSite Not Available
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang,
ChinaSite Not Available
Affiliated Hospital of North Sichuan Medical College
Nanchong,
ChinaSite Not Available
Gulou Hospital Affiliated to Nanjing University Gulou Hospital Affiliated to Nanjing University
Nanjing,
ChinaSite Not Available
Zhongda Hospital Southeast University
Nanjing,
ChinaSite Not Available
Affiliated Hospital of Nantong University
Nantong,
ChinaSite Not Available
Ningbo Huamei Hospital, University of Chinese Academy of Sciences
Ningbo,
ChinaSite Not Available
Changhai Hospital of Shanghai
Shanghai,
ChinaSite Not Available
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an,
ChinaSite Not Available
Qinghai Province People's Hospital
Xining,
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou,
ChinaSite Not Available
Zigong Fourth People's Hospital
Zigong,
ChinaSite Not Available

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