CompletedPhase 3

A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients

South Korea612 participantsStarted 2023-03-21

Plain-language summary

A phase 3 clinical trial to compare and evaluate efficacy and safety of epaminurad with febuxostat in gout patients.

Age range19 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Medical history
✕. Concurrent disease or laboratory test abnormality
✕. History of gout flare between 2 weeks before written informed consent and immediately before randomization
✕. Any cardiovascular abnormalities that might affect the study
✕. Prior or planned treatment with xanthine oxidase inhibitors, uricosuric agents, or uricolytic agents
✕. Prior or planned treatment with drugs acting on human uric acid transporter 1 or diuretics
✕. Prior or planned treatment with intravenous and oral high dose systemic corticosteroids, mercaptopurine, azathioprine, or theophylline
✕. Hypersensitivity to the IP (epaminurad or febuxostat)

Proportion of subjects with sUA (serum uric acid) <6 mg/dL at the last 3 time points during the main study period

Timeframe: Week 24

NCT IDNCT05815901

SponsorJW Pharmaceutical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-26