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NCT05815901 | RECRUITING | Gout

A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients
Sponsor:

JW Pharmaceutical

Brief Summary:

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

Condition or disease

Gout

Intervention/treatment

Epaminurad 6 mg

Epaminurad 9 mg

Febuxostat 40 mg

Febuxostat 80 mg

Epaminurad 6 mg placebo

Epaminurad 9 mg placebo

Febuxostat 40 mg placebo

Febuxostat 80 mg placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 588 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2023-03-14
Estimated Primary Completion Date : 2025-08
Estimated Study Completion Date : 2025-08

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * for screening
  • 1. ≥19 to ≤75 years of age at the time of written informed consent
  • 2. Diagnosed record with gout, or ACR/EULAR 2015 score ≥8
  • 3. Able and willing to actively participate in TLC programme
  • 4. Signed ICF for voluntary study participation
  • * for randomization
  • 1. sUA level ≥7.0 mg/dL
  • 2. ACR/EULAR 2015 score ≥8
Exclusion Criteria
  • 1. Medical history
  • Malignant tumor, Urolithiasis within 5 years, Hypersensitivity disease, Lesch-Nyhan syndrome, Hereditary problems, Ischemic heart disease, Prior or planned organ transplant recipient.
  • 2. 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
  • 3. History of gout flare between 2 weeks before written informed consent and immediately before randomization
  • 4. Any cardiovascular abnormalities that might affect the study
  • 5. Prior or planned treatment with xanthine oxidase inhibitors, uricosuric agents, or uricolytic agents
  • 6. Prior or planned treatment with drugs acting on human uric acid transporter 1 or diuretics
  • 7. Prior or planned treatment with intravenous and oral high dose systemic corticosteroids, mercaptopurine, azathioprine, or theophylline
  • 8. Hypersensitivity to the IP (epaminurad or febuxostat)
  • 9. Pregnant or lactating woman.
A Therapeutic Confirmatory Study of Epaminurad Versus Febuxostat in Gout Patients

Location Details

NCT05815901

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Korea, Republic of,

Inha University Hospital

Incheon, Korea, Republic of,