MedTrace Logo

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

NCT05007392 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 451

Last updated 2025-07-30

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-21
Primary Completion
2023-06-14
Completion
2023-06-14

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05007392 on ClinicalTrials.gov