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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT02082769
Eligibility Criteria:
Inclusion Criteria:
* Hyperuricemia (serum urate ≥8.0 mg/dL) and gout by Chinese Rheumatism Association Criteria;
* Renal function defined as a serum creatinine level of \< 2.0 mg/dL and creatinine clearance of \> 20 milliliters per minute (mL/min) by Cockcroft and Gault formula;
* No gout flare 2 weeks beforehand during 2-week screening period.
Exclusion Criteria:
* Pregnancy or lactation;
* Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, or medications containing aspirin (\>325 mg) or other salicylates;
* Body Mass Index (BMI) \>50 kilogram per meter²(kg/m²);
* A history of active liver disease, or hepatic dysfunction;
* A history of bronchial asthma;
* A history of renal calculi or thyroid disease;
* Secondary gout Joint diseases induced by rheumatoid arthritis, psoriatic arthritis and bone tumor;
* Intolerance to allopurinol and Ibuprofen;
* Alcohol intake of ≥ 14 drinks/week;
* Clinically significant medical condition.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02082769
Study Brief:
Protocol Section:
NCT02082769