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NCT05007392 | COMPLETED | Gout

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

Are you Co., Ltd.

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.

Condition or disease

Gout

Intervention/treatment

Dotinurad

Febuxostat

Dotinurad Matched Placebo

Febuxostat Matched Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 451 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Randomized, Multicenter, Double-Blind, Superiority Study of Dotinurad (4 mg) and Febuxostat (40 mg) for the Treatment of Subjects With Gout
Actual Study Start Date : 2021-12-21
Estimated Primary Completion Date : 2023-06-14
Estimated Study Completion Date : 2023-06-14

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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)
A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout

Location Details

NCT05007392

Please Choose a site

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

Not yet recruiting

China, Anhui

Anhui Provincial Hospital

Hefei, Anhui, China, 230001

Not yet recruiting

China, Beijing

Beijing Anzhen Hospital,Capital Medical University

Beijing, Beijing, China, 100029

Not yet recruiting

China, Beijing

Beijing Hospital

Beijing, Beijing, China, 100034

Not yet recruiting

China, Beijing

Peking University First Hospital

Beijing, Beijing, China, 100034

Not yet recruiting

China, Beijing

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

Beijing, Beijing, China, 101100

Not yet recruiting

China, Guangdong

Foshan First People's Hospital

Foshan, Guangdong, China, 528000

Not yet recruiting

China, Guangdong

Guangzhou First People's Hospital

Guangzhou, Guangdong, China, 510080

Not yet recruiting

China, Guangdong

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510280

Not yet recruiting

China, Guangdong

J IE Yang peoples hospital

J IElike, Guangdong, China,

Not yet recruiting

China, Guangdong

The Seventh Affiliated Hospital of Sun Yat-sen University

Shenzhen, Guangdong, China, 200090

Not yet recruiting

China, Guangdong

Shenzhen People's Hospital

Shenzhen, Guangdong, China, 518020

Not yet recruiting

China, Hainan

Hainan General Hospital

Haikou, Hainan, China, 570311

Not yet recruiting

China, Hubei

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

Wuhan, Hubei, China, 430030

Not yet recruiting

China, Hunan

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China, 410013

Not yet recruiting

China, Inner Mongolia

First Affiliated Hospital of Inner Mongolia technological University

B Aotou, Inner Mongolia, China, 14010

Not yet recruiting

China, Inner Mongolia

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China, 10050

Not yet recruiting

China, Jiangsu

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China, 210300

Not yet recruiting

China, Jiangsu

Nanjing Medical University Affiliated 2nd Hospital

Nanjing, Jiangsu, China, 210011

Not yet recruiting

China, Jiangsu

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China, 225000

Not yet recruiting

China, Jiangxi

Jiang ping people hospital

Pingxiang, Jiangxi, China, 337055

Not yet recruiting

China, Jilin

Jilin Province People's Hospital

Changchun, Jilin, China, 130021

Not yet recruiting

China, Jilin

The First Hospital of Jilin University

Changchun, Jilin, China, 130021

Not yet recruiting

China, Jilin

Yanbian University Hospital

Which one, Jilin, China, 133000

Not yet recruiting

China, Liaoning

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China, 116011

Not yet recruiting

China, Liaoning

Dalian Municipal Central Hospital Affiliated of Dalian Medical University

Dalian, Liaoning, China, 116021

Not yet recruiting

China, Liaoning

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China, 116023

Not yet recruiting

China, Shandong

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China, 266000

Not yet recruiting

China, Shanghai

Tong Ren Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai, China, 200050

Not yet recruiting

China, Shanghai

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Shanghai, Shanghai, China, 200052

Not yet recruiting

China, Yunnan

The First People's Hospital of Yunnan Province

Kunming, Yunnan, China, 650032