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

Gout Clinical Trial

Official title:

A Randomized, Multicenter, Double-Blind, Superiority Study of Dotinurad (4 mg) and Febuxostat (40 mg) for the Treatment of Subjects With Gout

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05007392
• Other study ID #: FYU-981-J086-301
• Status: Completed
• Phase: Phase 3
• Start date: December 21, 2021
• Est. completion date: June 14, 2023

Study information

• Verified date: July 2023
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: June 14, 2023
• Est. primary completion date: June 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Gout

Intervention

Drug:
• Dotinurad
Dotinurad oral tablets.
• Febuxostat
Febuxostat oral tablets.

Other:
• Dotinurad Matched Placebo
Dotinurad matched placebo oral tablets.
• Febuxostat Matched Placebo
Febuxostat matched placebo oral tablets.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieve Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24		Week 24
Secondary	Percentage of Participants Who Achieve SUA Level <=6.0 mg/dL at Week 12		Week 12
Secondary	Percentage of Participants Who Achieve SUA Level <=6.0 mg/dL up to Week 24		Up to Week 24
Secondary	Mean Percent Reduction From Baseline in SUA Level in Participants up to Week 24		Baseline up to Week 24
Secondary	Mean Change From Baseline in SUA Level in Participants up to Week 24		Baseline up to Week 24
Secondary	Mean SUA Level in Participants up to Week 24		Up to Week 24