drugset / Trial / NCT05007392

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

NCT05007392

Phase 3 Completed 451 enrolled Eisai Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Dotinurad Small molecule 4 mg Oral
Comparator Febuxostat Small molecule 40 mg Oral

Indications