Trials / Completed
CompletedNCT05007392
A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout
A Randomized, Multicenter, Double-Blind, Superiority Study of Dotinurad (4 mg) and Febuxostat (40 mg) for the Treatment of Subjects With Gout
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 451 (actual)
- Sponsor
- Eisai Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dotinurad | Dotinurad oral tablets. |
| DRUG | Febuxostat | Febuxostat oral tablets. |
| OTHER | Dotinurad Matched Placebo | Dotinurad matched placebo oral tablets. |
| OTHER | Febuxostat Matched Placebo | Febuxostat matched placebo oral tablets. |
Timeline
- Start date
- 2021-12-21
- Primary completion
- 2023-06-14
- Completion
- 2023-06-14
- First posted
- 2021-08-16
- Last updated
- 2025-07-30
- Results posted
- 2025-07-30
Locations
30 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05007392. Inclusion in this directory is not an endorsement.