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

Last updated: August 1, 2023
Sponsor: Eisai Co., Ltd.
Overall Status: Completed

Phase

3

Condition

Bone Diseases

Arthritis And Arthritic Pain (Pediatric)

Musculoskeletal Diseases

Treatment

Febuxostat Matched Placebo

Febuxostat

Dotinurad Matched Placebo

Clinical Study ID

NCT05007392
FYU-981-J086-301
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Gout participant (with a history of gout attack or concurrent gouty tophi) with SUAlevel greater than (>) 7.0 mg/dL in the screening phase (within 14 days prior torandomization)
  2. Male or female participant with age greater than or equal to (>=) 18 years at the timeof informed consent
  3. Provide written informed consent signed by the participant prior to entering the studyor undergoing any study procedures, indicating that they understand the purpose andprocedures required for the study and are willing to participate in the study

Exclusion

Exclusion Criteria:

  1. Has gouty arthritis that has not resolved within 14 days prior to randomization
  2. Has secondary hyperuricemia
  3. Comorbidities with nephrolithiasis or clinical urinary calculi (example, haematuria,back pain)
  4. Evidence of clinically significant disease (example, cardiac disease: heart failureand angina unstable, respiratory, gastrointestinal, renal, or neurological disease:cerebral infarction) that in the opinion of the investigator could affect theparticipant's safety or interfere with the study assessments
  5. Evidence of clinical significant hepatic disease: refer to Grade 2 in the "SeriousnessGrading Criteria for Adverse Drug Reactions" or aspartate aminotransferase (AST) oralanine aminotransferase (ALT) >3 multiple (*) upper limit of normal (ULN) in thescreening phase
  6. Estimated glomerular filtration rate (eGFR) of less than (<) 30 milliliter perminute/1.73 square meters in the screening phase
  7. Systolic blood pressure of >=180 millimetre of mercury (mmHg) or diastolic bloodpressure of >=110 mmHg in the screening phase
  8. Hemoglobin A1c National Glycohemoglobin Standardization Program (NGSP) value of >=8.4percent (%) in the screening phase
  9. Hypersensitivity to the study drugs (dotinurad or febuxostat) or their excipients, orall of urine alkalinizer (potassium citrate/sodium citrate hydrate compoundpreparations)

Study Design

Total Participants: 451
Treatment Group(s): 4
Primary Treatment: Febuxostat Matched Placebo
Phase: 3
Study Start date:
December 21, 2021
Estimated Completion Date:
June 14, 2023

Connect with a study center

  • Anhui Provincial Hospital

    Hefei, Anhui 230001
    China

    Site Not Available

  • Beijing Anzhen Hospital,Capital Medical University

    Beijing, Beijing 100029
    China

    Site Not Available

  • Beijing Hospital

    Beijing, Beijing 100034
    China

    Site Not Available

  • Beijing Tongzhou District Luhe Hospital, Beijing, P.R.China

    Beijing, Beijing 101100
    China

    Site Not Available

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Site Not Available

  • Foshan First People's Hospital

    Foshan, Guangdong 528000
    China

    Site Not Available

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong 510280
    China

    Site Not Available

  • Jieyang People's Hospital

    Jieyang, Guangdong
    China

    Site Not Available

  • Shenzhen People's Hospital

    Shenzhen, Guangdong 518020
    China

    Site Not Available

  • The Seventh Affiliated Hospital of Sun Yat-sen University

    Shenzhen, Guangdong 200090
    China

    Site Not Available

  • Hainan General Hospital

    Haikou, Hainan 570311
    China

    Site Not Available

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

    Wuhan, Hubei 430030
    China

    Site Not Available

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan 410013
    China

    Site Not Available

  • First Affiliated Hospital of Inner Mongolia technological University

    Baotou, Inner Mongolia 14010
    China

    Site Not Available

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia 10050
    China

    Site Not Available

  • The First People's Hospital of Changzhou

    Changzhou, Jiangsu 210300
    China

    Site Not Available

  • Nanjing Medical University Affiliated 2nd Hospital

    Nanjing, Jiangsu 210011
    China

    Site Not Available

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu 225000
    China

    Site Not Available

  • Jiangxi Pingxiang People's Hospital

    Pingxiang, Jiangxi 337055
    China

    Site Not Available

  • Jilin Province People's Hospital

    Changchun, Jilin 130021
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • Yanbian University Hospital

    Yanji, Jilin 133000
    China

    Site Not Available

  • Dalian Municipal Central Hospital Affiliated of Dalian Medical University

    Dalian, Liaoning 116021
    China

    Site Not Available

  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning 116011
    China

    Site Not Available

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning 116023
    China

    Site Not Available

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong 266000
    China

    Site Not Available

  • Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

    Shanghai, Shanghai 200052
    China

    Site Not Available

  • Tong Ren Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200050
    China

    Site Not Available

  • The First People's Hospital of Yunnan Province

    Kunming, Yunnan 650032
    China

    Site Not Available

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