Clinical trial NCT05007392: A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout
Official title: A Randomized, Multicenter, Double-Blind, Superiority Study of Dotinurad (4 mg) and Febuxostat (40 mg) for the Treatment of Subjects With Gout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gout
Keywords: Dotinurad
Febuxostat
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-16
Enrollment: 451
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purpose of the study is to confirm the efficacy of dotinurad 4 milligram (mg) to febuxostat 40 mg on the percentage of participants achieving a serum uric acid (SUA) level less than or equal to (\<=) 6.0 milligrams per deciliter (mg/dL) at Week 24 in Chinese participants with gout.


Eligibility criteria: Inclusion Criteria:

1. Gout participant (with a history of gout attack or concurrent gouty tophi) with SUA level greater than (\>) 7.0 mg/dL in the screening phase (within 14 days prior to randomization)
2. Male or female participant with age greater than or equal to (\>=) 18 years at the time of informed consent
3. Provide written informed consent signed by the participant prior to entering the study or undergoing any study procedures, indicating that they understand the purpose and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

1. Has gouty arthritis that has not resolved within 14 days prior to randomization
2. Has secondary hyperuricemia
3. Comorbidities with nephrolithiasis or clinical urinary calculi (example, haematuria, back pain)
4. Evidence of clinically significant disease (example, cardiac disease: heart failure and angina unstable, respiratory, gastrointestinal, renal, or neurological disease: cerebral infarction) that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments
5. Evidence of clinical significant hepatic disease: refer to Grade 2 in the "Seriousness Grading Criteria for Adverse Drug Reactions" or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 multiple (\*) upper limit of normal (ULN) in the screening phase
6. Estimated glomerular filtration rate (eGFR) of less than (\<) 30 milliliter per minute/1.73 square meters in the screening phase
7. Systolic blood pressure of \>=180 millimetre of mercury (mmHg) or diastolic blood pressure of \>=110 mmHg in the screening phase
8. Hemoglobin A1c National Glycohemoglobin Standardization Program (NGSP) value of \>=8.4 percent (%) in the screening phase
9. Hypersensitivity to the study drugs (dotinurad or febuxostat) or their excipients, or all of urine alkalinizer (potassium citrate/sodium citrate hydrate compound preparations)

Primary outcomes:
measure: Percentage of Participants Who Achieve Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants Who Achieve SUA Level <=6.0 mg/dL at Week 12
timeFrame: Week 12
measure: Percentage of Participants Who Achieve SUA Level <=6.0 mg/dL up to Week 24
timeFrame: Up to Week 24
measure: Mean Percent Reduction From Baseline in SUA Level in Participants up to Week 24
timeFrame: Baseline up to Week 24
measure: Mean Change From Baseline in SUA Level in Participants up to Week 24
timeFrame: Baseline up to Week 24
measure: Mean SUA Level in Participants up to Week 24
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Anzhen Hospital,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tongzhou District Luhe Hospital, Beijing, P.R.China
state: Beijing
city: Foshan
country: China
facility: Foshan First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Jieyang
country: China
facility: Jieyang People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The Seventh Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Baotou
country: China
facility: First Affiliated Hospital of Inner Mongolia technological University
state: Inner Mongolia
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Changzhou
country: China
facility: The First People's Hospital of Changzhou
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Medical University Affiliated 2nd Hospital
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Pingxiang
country: China
facility: Jiangxi Pingxiang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: Jilin Province People's Hospital
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Yanji
country: China
facility: Yanbian University Hospital
state: Jilin
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: Dalian Municipal Central Hospital Affiliated of Dalian Medical University
state: Liaoning
city: Dalian
country: China
facility: The Second Hospital of Dalian Medical University
state: Liaoning
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Tong Ren Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
state: Shanghai
city: Kunming
country: China
facility: The First People's Hospital of Yunnan Province
state: Yunnan
Study officials:
References: