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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT04012294
Eligibility Criteria:
Inclusion Criteria:
* Individuals with two urate determinations \>7 mg/dL in the last year and no clinical sign, past or present, suggestive of joint inflammation (acute gout attack), urolithiasis or uric acid nephropathy
* Over 18 years of age
* Residents of Mexico City or its metropolitan area
* Individuals with a signed informed consent form for the participation in the clinical trial
Exclusion Criteria:
* Individuals with joint inflammation suggestive of gout during the clinical evaluation
* Patients without elemental ultrasonographic lesions (double contour sign, aggregates, tophi) on the first metatarsophalangeal joint, knee, ankle or the tendons of the quadriceps, patella, and calcaneus when evaluated by MSUS
* Patients taking thiazides
* Patients with history of stroke or coronary artery disease in the last year
* Patients with osteoarthritis be it by clinical presentation or imaging
* Pregnant women
* Neoplasms
* Known Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) , Human immunodeficiency Virus (HIV) infection, or any other know active infections
* Autoimmune or autoinflammatory disease
* Allopurinol hypersensitivity or allergy
* Deteriorated kidney function (Glomerular Filtration Rate (GFR) \<50 mL/min/1.73m\^2)
* Patients taking azathioprine
* Functional New York Heart Association (NYHA) score of II or more
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04012294
Study Brief:
Protocol Section:
NCT04012294