A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout
Phase 3
Completed
- Conditions
- Gout
- Interventions
- Registration Number
- NCT05007392
- Lead Sponsor
- Eisai 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 451
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Drug: Dotinurad + Febuxostat Matched Placebo Febuxostat Matched Placebo 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). Drug: Febuxostat + Dotinurad Matched Placebo Dotinurad Matched Placebo 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). Drug: Febuxostat + Dotinurad Matched Placebo Febuxostat 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). Drug: Dotinurad + Febuxostat Matched Placebo Dotinurad 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).
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Achieve Serum Uric Acid (SUA) Level <=6.0 mg/dL at Week 24 Week 24
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieve SUA Level <=6.0 mg/dL up to Week 24 Up to Week 24 Mean Percent Reduction From Baseline in SUA Level in Participants up to Week 24 Baseline up to Week 24 Mean SUA Level in Participants up to Week 24 Up to Week 24 Percentage of Participants Who Achieve SUA Level <=6.0 mg/dL at Week 12 Week 12 Mean Change From Baseline in SUA Level in Participants up to Week 24 Baseline up to Week 24
Trial Locations
- Locations (30)
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Beijing Anzhen Hospital,Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Hospital
🇨🇳Beijing, Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China
Beijing Tongzhou District Luhe Hospital, Beijing, P.R.China
🇨🇳Beijing, Beijing, 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
Jieyang People's Hospital
🇨🇳Jieyang, Guangdong, China
The Seventh Affiliated Hospital of Sun Yat-sen University
🇨🇳Shenzhen, Guangdong, China
Scroll for more (20 remaining)Anhui Provincial Hospital🇨🇳Hefei, Anhui, China