A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout

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.

Timeline

Start

2021-12-21

Primary completion

2023-06-14

Completion

2023-06-14

Outcome

Met primary endpoint

registry analysis (superiority test); Febuxostat vs Dotinurad; p <0.001; Difference of percentage 35.87 (95% CI 27.36 to 44.37); Cochran-Mantel-Haenszel NCT05007392 ↗

Drugs

Indications