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Clinical Trials List

Protocol NumberJW21301

NCT Number(ClinicalTrials.gov Identfier)NCT05815901

2022-12-14 - 2026-01-01

Phase III

Not yet recruiting1

Recruiting12

A Multi-center, Randomized, Double-blind, Active-controlled, Therapeutic Confirmatory, Phase III Study to Compare and Evaluate the Efficacy and Safety of Epaminurad With Febuxostat in Gout Patients

Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator Chung-Ming Huang 無

China Medical University Hospital

Co-Principal Investigator

Po-Hao Huang 無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator WEN-NAN HUANG 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴寧生無

Dalin Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳宏安無

Chi Mei Medical Center

Co-Principal Investigator

林永章無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TianMing Zhan 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王鈺維醫師無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

陳英州無

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 林科名醫師無

Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林孝義無

Cheng Hsin General Hospital

Co-Principal Investigator

徐翊庭醫師無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳正欽無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 朱志勳醫師無

Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHENG-HAN WU 無

National Taiwan University Hospital Hsin-Chu Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chi-Ching Chang 無

Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Ching Yang Division of Family Medicine

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Gout

Objectives

Epaminurad lozenge is an investigational drug that is undergoing clinical trials. It is currently not approved for general use by any regulatory authority. A total of seven clinical trials, including Phase 1 and Phase 2 trials, were conducted in healthy adults, adults with renal insufficiency, and adults with gout to evaluate the safety and efficacy of epaminurad tablets. The aim of this phase 3 trial was to confirm the serum uric acid-lowering effect and safety of its epaminurad tablet formulation compared with febuxostat in patients with gout.

Test Drug

Epaminurad

Active Ingredient

Epaminurad

Dosage Form

tablet

Dosage

6mg and 9mg

Endpoints

Evaluation of the efficacy of epaminurad tablets (hereafter referred to as epaminurad tablets) in reducing serum uric acid (sUA) in patients with gout
"epaminurad") was non-inferior to febuxostat.

Inclution Criteria

Inclusion Criteria:

for screening

≥19 to ≤75 years of age at the time of written informed consent
Diagnosed record with gout, or ACR/EULAR 2015 score ≥8
Able and willing to actively participate in TLC programme
Signed ICF for voluntary study participation
for randomization

sUA level ≥7.0 mg/dL
ACR/EULAR 2015 score ≥8

Exclusion Criteria

Exclusion Criteria:

Medical history

Malignant tumor, Urolithiasis within 5 years, Hypersensitivity disease, Lesch-Nyhan syndrome, Hereditary problems, Ischemic heart disease, Prior or planned organ transplant recipient.

Concurrent disease or laboratory test abnormality

Uncontrolled diabetes mellitus, Uncontrolled hypertension, Uncontrolled dyslipidemia, AST or ALT ≥2×ULN, total bilirubin ≥1.5×ULN, eGFR <30 mL/min/1.73m^2, Uncontrolled thyroid dysfunction, HIV, HBV or HCV positive, Drug and alcohol abuse, BMI ≥40 kg/m^2

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)
Pregnant or lactating woman.

The Estimated Number of Participants

Taiwan

206 participants
Global

588 participants