The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with hyperuricemia associated with gout.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
500
Over-encapsulated tablets containing active drug substance administered orally (PO).
Over-encapsulated tablets containing active drug substance administered PO.
Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24
Time frame: Week 24
Percentage of Participants With an sUA Level <6.0 mg/dL at Weeks 16, 20 and 24 Inclusive
Time frame: Weeks 16, 20 and 24
Mean Rate of Gout Flares Requiring Treatment From Week 36 Through Week 64
Time frame: Week 36 through Week 64
Percentage of Participants With an sUA level <5.0 mg/dL at Week 24 and no Gout Flares Requiring Treatment From Week 36 Through Week 64
Time frame: Week 24 and Week 36 through Week 64
Mean Change From Baseline in sUA at Week 24
Time frame: Baseline and Week 24
Percentage of Participants who do not Have a Gout Flare Requiring Treatment From Week 24 Through Week 64
Time frame: Week 24 through Week 64
Percentage of Participants With an sUA Level <6.0 mg/dL at Each Visit
Time frame: Up to Week 68
Percentage of Participants With an sUA Level <5.0 mg/dL at Each Visit
Time frame: Up to Week 68
Percentage of Participants With an sUA Level <4.0 mg/dL at Each Visit
Time frame: Up to Week 68
Absolute Change from Baseline in sUA Levels at Each Visit
Time frame: Baseline to Week 68
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University of Alabama at Birmingham
Birmingham, Alabama, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Covina, California, United States
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Dublin, California, United States
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Norco, California, United States
RECRUITING...and 85 more locations
Percent Change from Baseline in sUA Levels at Each Visit
Time frame: Baseline to Week 68
Percentage of Participants With a Gout Flare Requiring Treatment at Each Month Between Week 24 and the end of Study
Time frame: Week 24 to Week 68
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 through Week 68
Percentage of Participants With Serious Adverse Events (SAEs)
Time frame: Day 1 through Week 68