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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT01988402
Eligibility Criteria:
Inclusion Criteria requires both of:
* Crystal proven gout, and
* An acute gout attack within 72 hours of first treatment
Plus one of the following:
* At least 2 gout attacks in past 12 months
* Tophus
* Nephrolithiasis
* 24hr urine uric acid greater than 1000mg
Exclusion Criteria:
* Inability to return for examinations
* Glomerular filtration rate (calculated) less than 50 milliliters per minute
* Allopurinol use in past 6 months
* Ongoing cancer therapy
* Concomitant azathioprine or cyclophosphamide
* Any one of the following liver enzymes greater than 1.25 times the upper limit of normal:
* AST \[Aspartate aminotransferase\]
* ALT \[Alanine aminotransferase\]
* alkaline phosphatase
* Pre-gout pain in involved joint of more than 3 on a scale of 1-10
* Neurologic deficit around the involved joint
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01988402
Study Brief:
Protocol Section:
NCT01988402