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 @ 4:52 AM
Ignite Modification Date:
2025-12-25 @ 4:52 AM
NCT ID:
NCT02287818
Eligibility Criteria:
Inclusion Criteria:
1. Male or female age 20 to 65 years, inclusive.
2. Meets ≥6 of the 12 American College of Rheumatology preliminary criteria (1977) for the classification of acute arthritis of primary gout (Appendix 2), OR have proven tophus or documented monosodium urate (MSU) crystals in the joint fluid.
3. Serum uric acid ≥7.5 mg/dL and ≤10 mg/dL at screening with ≥1 gouty arthritis flare within one year prior to screening, OR serum uric acid ≥9 mg/dL and ≤10 mg/dL at screening with or without prior gout flares.
Exclusion Criteria:
1. Use of allopurinol, febuxostat, benzbromarone, probenecid, or sulfinpyrazone within 2 weeks prior to screening.
2. Occurrence of a gouty arthritis flare within 1 week prior to screening or during the screening period through baseline.
3. Use of colchicine within 1 week prior to screening.
4. Use of Glucocorticoids, NSAIDs or COX-2 inhibitors within 1 week prior to screening.
5. Allergy, contraindication, or intolerance to febuxostat.
6. Severe renal impairment.
7. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) concentration \>2 times the upper limit of laboratory normal range (\>2x ULN) at screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT02287818
Study Brief:
Protocol Section:
NCT02287818