At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 451 enrolled
Drug / intervention
Dotinurad +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Multicenter, Double-Blind, Superiority Study of Dotinurad (4 mg) and Febuxostat (40 mg) for the Treatment of Subjects With Gout
In Brief
A Phase 3 clinical trial evaluating Dotinurad, Febuxostat, and 2 other interventions for Gout. Completed, enrolled 451 participants across 30 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedAug 2021
Enrollment StartDec 2021
Primary CompletionJun 2023
TodayJul 2026
First PostedAug 16, 2021
Enrollment StartDec 21, 2021
Primary CompletionJun 14, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.9 years ago
Interventions
Dotinuraddrug
Dotinurad oral tablets.
Febuxostatdrug
Febuxostat oral tablets.
Dotinurad Matched Placeboother
Dotinurad matched placebo oral tablets.
Febuxostat Matched Placeboother
Febuxostat matched placebo oral tablets.