Phase
Condition
Bone Diseases
Arthritis And Arthritic Pain (Pediatric)
Musculoskeletal Diseases
Treatment
Febuxostat Matched Placebo
Febuxostat
Dotinurad Matched Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Gout participant (with a history of gout attack or concurrent gouty tophi) with SUAlevel greater than (>) 7.0 mg/dL in the screening phase (within 14 days prior torandomization)
- Male or female participant with age greater than or equal to (>=) 18 years at the timeof informed consent
- Provide written informed consent signed by the participant prior to entering the studyor undergoing any study procedures, indicating that they understand the purpose andprocedures required for the study and are willing to participate in the study
Exclusion
Exclusion Criteria:
- Has gouty arthritis that has not resolved within 14 days prior to randomization
- Has secondary hyperuricemia
- Comorbidities with nephrolithiasis or clinical urinary calculi (example, haematuria,back pain)
- Evidence of clinically significant disease (example, cardiac disease: heart failureand angina unstable, respiratory, gastrointestinal, renal, or neurological disease:cerebral infarction) that in the opinion of the investigator could affect theparticipant's safety or interfere with the study assessments
- Evidence of clinical significant hepatic disease: refer to Grade 2 in the "SeriousnessGrading Criteria for Adverse Drug Reactions" or aspartate aminotransferase (AST) oralanine aminotransferase (ALT) >3 multiple (*) upper limit of normal (ULN) in thescreening phase
- Estimated glomerular filtration rate (eGFR) of less than (<) 30 milliliter perminute/1.73 square meters in the screening phase
- Systolic blood pressure of >=180 millimetre of mercury (mmHg) or diastolic bloodpressure of >=110 mmHg in the screening phase
- Hemoglobin A1c National Glycohemoglobin Standardization Program (NGSP) value of >=8.4percent (%) in the screening phase
- Hypersensitivity to the study drugs (dotinurad or febuxostat) or their excipients, orall of urine alkalinizer (potassium citrate/sodium citrate hydrate compoundpreparations)
Study Design
Connect with a study center
Anhui Provincial Hospital
Hefei, Anhui 230001
ChinaSite Not Available
Beijing Anzhen Hospital,Capital Medical University
Beijing, Beijing 100029
ChinaSite Not Available
Beijing Hospital
Beijing, Beijing 100034
ChinaSite Not Available
Beijing Tongzhou District Luhe Hospital, Beijing, P.R.China
Beijing, Beijing 101100
ChinaSite Not Available
Peking University First Hospital
Beijing, Beijing 100034
ChinaSite Not Available
Foshan First People's Hospital
Foshan, Guangdong 528000
ChinaSite Not Available
Guangzhou First People's Hospital
Guangzhou, Guangdong 510080
ChinaSite Not Available
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong 510280
ChinaSite Not Available
Jieyang People's Hospital
Jieyang, Guangdong
ChinaSite Not Available
Shenzhen People's Hospital
Shenzhen, Guangdong 518020
ChinaSite Not Available
The Seventh Affiliated Hospital of Sun Yat-sen University
Shenzhen, Guangdong 200090
ChinaSite Not Available
Hainan General Hospital
Haikou, Hainan 570311
ChinaSite Not Available
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei 430030
ChinaSite Not Available
The Third Xiangya Hospital of Central South University
Changsha, Hunan 410013
ChinaSite Not Available
First Affiliated Hospital of Inner Mongolia technological University
Baotou, Inner Mongolia 14010
ChinaSite Not Available
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia 10050
ChinaSite Not Available
The First People's Hospital of Changzhou
Changzhou, Jiangsu 210300
ChinaSite Not Available
Nanjing Medical University Affiliated 2nd Hospital
Nanjing, Jiangsu 210011
ChinaSite Not Available
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu 225000
ChinaSite Not Available
Jiangxi Pingxiang People's Hospital
Pingxiang, Jiangxi 337055
ChinaSite Not Available
Jilin Province People's Hospital
Changchun, Jilin 130021
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, Jilin 130021
ChinaSite Not Available
Yanbian University Hospital
Yanji, Jilin 133000
ChinaSite Not Available
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
Dalian, Liaoning 116021
ChinaSite Not Available
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning 116011
ChinaSite Not Available
The Second Hospital of Dalian Medical University
Dalian, Liaoning 116023
ChinaSite Not Available
The Affiliated Hospital of Qingdao University
Qingdao, Shandong 266000
ChinaSite Not Available
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Shanghai, Shanghai 200052
ChinaSite Not Available
Tong Ren Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai 200050
ChinaSite Not Available
The First People's Hospital of Yunnan Province
Kunming, Yunnan 650032
ChinaSite Not Available
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