Dotinurad
DrugDotinurad oral tablets.
Other names: FYU-981
NCT Number: NCT05007392
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Anhui Provincial Hospital, Hefei, Anhui, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dotinurad oral tablets.
Other names: FYU-981
Febuxostat oral tablets.
Dotinurad matched placebo oral tablets.
Febuxostat matched placebo oral tablets.
Time frame: At Week 24
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 12
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 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: Baseline, 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 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 was reported.
Eisai Co., Ltd.
Industry
A Randomized, Multicenter, Double-Blind, Superiority Study of Dotinurad (4 mg) and Febuxostat (40 mg) for the Treatment of Subjects With Gout
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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