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:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT05253833
Eligibility Criteria:
Inclusion Criteria:
* History of gout
* at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 30 mm in the longest diameter.
* Patients who are NOT on approved ULT must have sUA \> 7 mg/dL
* Patients who are on medically appropriate ULT must have sUA \> 6 mg/dL
* Estimated Glomerular Filtration Rate (eGFR) ≥ 45 mL/min/1.73m2
Exclusion Criteria:
* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin
* Pregnant or breastfeeding
* History of kidney stones
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05253833
Study Brief:
Protocol Section:
NCT05253833