Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-24 @ 3:30 PM
NCT ID:
NCT05007392
Eligibility 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05007392
Study Brief:
Protocol Section:
NCT05007392