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

Primary Purpose

Gout

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Dotinurad
Febuxostat
Dotinurad Matched Placebo
Febuxostat Matched Placebo
Sponsored by
Eisai Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gout focused on measuring Dotinurad, Febuxostat

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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 failure and angina unstable, respiratory, gastrointestinal, renal, or neurological disease: cerebral infarction) that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments
  5. Evidence of clinical significant hepatic disease: refer to Grade 2 in the "Seriousness Grading Criteria for Adverse Drug Reactions" or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 multiple (*) upper limit of normal (ULN) in the screening phase
  6. Estimated glomerular filtration rate (eGFR) of less than (<) 30 milliliter per minute/1.73 square meters in the screening phase
  7. Systolic blood pressure of >=180 millimetre of mercury (mmHg) or diastolic blood pressure of >=110 mmHg in the screening phase
  8. Hemoglobin A1c National Glycohemoglobin Standardization Program (NGSP) value of >=8.4 percent (%) in the screening phase
  9. Hypersensitivity to the study drugs (dotinurad or febuxostat) or their excipients, or all of urine alkalinizer (potassium citrate/sodium citrate hydrate compound preparations)

Sites / Locations

  • Anhui Provincial Hospital
  • Beijing Anzhen Hospital,Capital Medical University
  • Beijing Hospital
  • Peking University First Hospital
  • Beijing Tongzhou District Luhe Hospital, Beijing, P.R.China
  • Foshan First People's Hospital
  • Guangzhou First People's Hospital
  • Zhujiang Hospital of Southern Medical University
  • Jieyang People's Hospital
  • The Seventh Affiliated Hospital of Sun Yat-sen University
  • Shenzhen People's Hospital
  • Hainan General Hospital
  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
  • The Third Xiangya Hospital of Central South University
  • First Affiliated Hospital of Inner Mongolia technological University
  • The Affiliated Hospital of Inner Mongolia Medical University
  • The First People's Hospital of Changzhou
  • Nanjing Medical University Affiliated 2nd Hospital
  • Northern Jiangsu People's Hospital
  • Jiangxi Pingxiang People's Hospital
  • Jilin Province People's Hospital
  • The First Hospital of Jilin University
  • Yanbian University Hospital
  • The First Affiliated Hospital of Dalian Medical University
  • Dalian Municipal Central Hospital Affiliated of Dalian Medical University
  • The Second Hospital of Dalian Medical University
  • The Affiliated Hospital of Qingdao University
  • Tong Ren Hospital Shanghai Jiaotong University School of Medicine
  • Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
  • The First People's Hospital of Yunnan Province

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Drug: Dotinurad + Febuxostat Matched Placebo

Drug: Febuxostat + Dotinurad Matched Placebo

Arm Description

Participants will receive one dotinurad 1 mg tablet and one febuxostat 20 mg matched placebo tablet, orally, once daily on Day 1 to Day 28 (up to 4 weeks) in Treatment 1 Phase; and then one dotinurad 2 mg tablet and two febuxostat 20 mg matched placebo tablets, orally, once daily on Day 29 to Day 84 (up to 8 weeks) followed by two dotinurad 2 mg tablets and two febuxostat 20 mg matched placebo tablets, orally, once daily on Day 85 to Day 168 (up to 12 weeks) in Treatment 2 Phase (Treatment 1 Phase=4 weeks; Treatment 2 Phase=20 weeks).

Participants will receive one febuxostat 20 mg tablet and one dotinurad 1 mg matched placebo tablet, orally, once daily on Day 1 to Day 28 (up to 4 weeks) in Treatment 1 Phase; and then two febuxostat 20 mg tablets and one dotinurad 2 mg matched placebo tablet, orally, once daily on Day 29 to Day 84 (up to 8 weeks) followed by two febuxostat 20 mg tablets and two dotinurad 2 mg matched placebo tablets, orally, once daily on Day 85 to Day 168 (up to 12 weeks) in Treatment 2 Phase (Treatment 1 Phase=4 weeks; Treatment 2 Phase=20 weeks).

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieve Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24

Secondary Outcome Measures

Percentage of Participants Who Achieve SUA Level <=6.0 mg/dL at Week 12
Percentage of Participants Who Achieve SUA Level <=6.0 mg/dL up to Week 24
Mean Percent Reduction From Baseline in SUA Level in Participants up to Week 24
Mean Change From Baseline in SUA Level in Participants up to Week 24
Mean SUA Level in Participants up to Week 24

Full Information

First Posted
August 11, 2021
Last Updated
August 1, 2023
Sponsor
Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05007392
Brief Title
A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout
Official Title
A Randomized, Multicenter, Double-Blind, Superiority Study of Dotinurad (4 mg) and Febuxostat (40 mg) for the Treatment of Subjects With Gout
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 21, 2021 (Actual)
Primary Completion Date
June 14, 2023 (Actual)
Study Completion Date
June 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gout
Keywords
Dotinurad, Febuxostat

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
451 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug: Dotinurad + Febuxostat Matched Placebo
Arm Type
Experimental
Arm Description
Participants will receive one dotinurad 1 mg tablet and one febuxostat 20 mg matched placebo tablet, orally, once daily on Day 1 to Day 28 (up to 4 weeks) in Treatment 1 Phase; and then one dotinurad 2 mg tablet and two febuxostat 20 mg matched placebo tablets, orally, once daily on Day 29 to Day 84 (up to 8 weeks) followed by two dotinurad 2 mg tablets and two febuxostat 20 mg matched placebo tablets, orally, once daily on Day 85 to Day 168 (up to 12 weeks) in Treatment 2 Phase (Treatment 1 Phase=4 weeks; Treatment 2 Phase=20 weeks).
Arm Title
Drug: Febuxostat + Dotinurad Matched Placebo
Arm Type
Active Comparator
Arm Description
Participants will receive one febuxostat 20 mg tablet and one dotinurad 1 mg matched placebo tablet, orally, once daily on Day 1 to Day 28 (up to 4 weeks) in Treatment 1 Phase; and then two febuxostat 20 mg tablets and one dotinurad 2 mg matched placebo tablet, orally, once daily on Day 29 to Day 84 (up to 8 weeks) followed by two febuxostat 20 mg tablets and two dotinurad 2 mg matched placebo tablets, orally, once daily on Day 85 to Day 168 (up to 12 weeks) in Treatment 2 Phase (Treatment 1 Phase=4 weeks; Treatment 2 Phase=20 weeks).
Intervention Type
Drug
Intervention Name(s)
Dotinurad
Other Intervention Name(s)
FYU-981
Intervention Description
Dotinurad oral tablets.
Intervention Type
Drug
Intervention Name(s)
Febuxostat
Intervention Description
Febuxostat oral tablets.
Intervention Type
Other
Intervention Name(s)
Dotinurad Matched Placebo
Intervention Description
Dotinurad matched placebo oral tablets.
Intervention Type
Other
Intervention Name(s)
Febuxostat Matched Placebo
Intervention Description
Febuxostat matched placebo oral tablets.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Achieve Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieve SUA Level <=6.0 mg/dL at Week 12
Time Frame
Week 12
Title
Percentage of Participants Who Achieve SUA Level <=6.0 mg/dL up to Week 24
Time Frame
Up to Week 24
Title
Mean Percent Reduction From Baseline in SUA Level in Participants up to Week 24
Time Frame
Baseline up to Week 24
Title
Mean Change From Baseline in SUA Level in Participants up to Week 24
Time Frame
Baseline up to Week 24
Title
Mean SUA Level in Participants up to Week 24
Time Frame
Up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gout participant (with a history of gout attack or concurrent gouty tophi) with SUA level greater than (>) 7.0 mg/dL in the screening phase (within 14 days prior to randomization) Male or female participant with age greater than or equal to (>=) 18 years at the time of informed consent Provide written informed consent signed by the participant prior to entering the study or undergoing any study procedures, indicating that they understand the purpose and procedures required for the study and are willing to participate in the study Exclusion Criteria: Has gouty arthritis that has not resolved within 14 days prior to randomization Has secondary hyperuricemia Comorbidities with nephrolithiasis or clinical urinary calculi (example, haematuria, back pain) Evidence of clinically significant disease (example, cardiac disease: heart failure and angina unstable, respiratory, gastrointestinal, renal, or neurological disease: cerebral infarction) that in the opinion of the investigator could affect the participant's safety or interfere with the study assessments Evidence of clinical significant hepatic disease: refer to Grade 2 in the "Seriousness Grading Criteria for Adverse Drug Reactions" or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 multiple (*) upper limit of normal (ULN) in the screening phase Estimated glomerular filtration rate (eGFR) of less than (<) 30 milliliter per minute/1.73 square meters in the screening phase Systolic blood pressure of >=180 millimetre of mercury (mmHg) or diastolic blood pressure of >=110 mmHg in the screening phase Hemoglobin A1c National Glycohemoglobin Standardization Program (NGSP) value of >=8.4 percent (%) in the screening phase Hypersensitivity to the study drugs (dotinurad or febuxostat) or their excipients, or all of urine alkalinizer (potassium citrate/sodium citrate hydrate compound preparations)
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
Beijing Anzhen Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Tongzhou District Luhe Hospital, Beijing, P.R.China
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101100
Country
China
Facility Name
Foshan First People's Hospital
City
Foshan
State/Province
Guangdong
ZIP/Postal Code
528000
Country
China
Facility Name
Guangzhou First People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510280
Country
China
Facility Name
Jieyang People's Hospital
City
Jieyang
State/Province
Guangdong
Country
China
Facility Name
The Seventh Affiliated Hospital of Sun Yat-sen University
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
200090
Country
China
Facility Name
Shenzhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570311
Country
China
Facility Name
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
First Affiliated Hospital of Inner Mongolia technological University
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
14010
Country
China
Facility Name
The Affiliated Hospital of Inner Mongolia Medical University
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
10050
Country
China
Facility Name
The First People's Hospital of Changzhou
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
210300
Country
China
Facility Name
Nanjing Medical University Affiliated 2nd Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210011
Country
China
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
ZIP/Postal Code
225000
Country
China
Facility Name
Jiangxi Pingxiang People's Hospital
City
Pingxiang
State/Province
Jiangxi
ZIP/Postal Code
337055
Country
China
Facility Name
Jilin Province People's Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Yanbian University Hospital
City
Yanji
State/Province
Jilin
ZIP/Postal Code
133000
Country
China
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Facility Name
Dalian Municipal Central Hospital Affiliated of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116021
Country
China
Facility Name
The Second Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116023
Country
China
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266000
Country
China
Facility Name
Tong Ren Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200050
Country
China
Facility Name
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200052
Country
China
Facility Name
The First People's Hospital of Yunnan Province
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Learn more about this trial

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

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