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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
451
Dotinurad oral tablets.
Febuxostat oral tablets.
Dotinurad matched placebo oral tablets.
Percentage of Participants With Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 (LOCF)
Percentage of participants with SUA level less than or equal to (\<=) 6.0 milligrams per deciliter (mg/dL) at Week 24 was reported. In case the SUA level was missing, this data was compensated by the last observation carried forward (LOCF) method.
Time frame: At Week 24
Percentage of Participants With SUA Level <=6.0 mg/dL at Week 12 (LOCF)
Percentage of participants with SUA level \<=6.0 mg/dL at Week 12 was reported. In case the SUA level was missing, this data was compensated by the LOCF method.
Time frame: At Week 12
Percentage of Participants With SUA Level <=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24
Percentage of participants with SUA level \<=6.0 mg/dL at Weeks 4, 8, 12, 16, 20 and 24 was reported. Data was reported for observed participants at specified visits.
Time frame: At Weeks 4, 8, 12, 16, 20 and 24
Mean Percent Reduction From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24
Mean percent reduction from baseline in SUA level at Weeks 4, 8, 12, 16, 20 and 24 was reported.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
Mean Change From Baseline in SUA Level at Weeks 4, 8, 12, 16, 20 and 24
Mean change from baseline in SUA level at Weeks 4, 8, 12, 16, 20 and 24 was reported.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
Mean SUA Level at Baseline, Weeks 4, 8, 12, 16, 20 and 24
Mean SUA level at Baseline, Weeks 4, 8, 12, 16, 20 and 24 was reported.
Time frame: Baseline, Weeks 4, 8, 12, 16, 20 and 24
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Febuxostat matched placebo oral tablets.
Anhui Provincial Hospital
Hefei, Anhui, China
Beijing Anzhen Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Tongzhou District Luhe Hospital, Beijing, P.R.China
Beijing, Beijing Municipality, China
Foshan First People's Hospital
Foshan, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Jieyang People's Hospital
Jieyang, Guangdong, China
The Seventh Affiliated Hospital of Sun Yat-sen University
Shenzhen, Guangdong, China
...and 20 more locations