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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT04130204
Eligibility Criteria:
Key Inclusion Criteria:
1. Females and males, age 18 to 75 years of age.
2. Diagnosis of gout using ACR/EULAR criteria (must have a score of equal to or greater than 8)
3. Subjects must have experienced ≥2 gout flares in the 12 months prior to screening;
4. Subjects that have not changed their urate lowering therapy (ULT) in the 2 weeks prior to the start of the gout flare and who will remain on the same dose throughout the follow-up period of the trial.
5. If taking NSAID, oral steroids, opioids, or other pain medications at standard doses (as stated on drug label) for pain unrelated to their gout flare, must be taking the same drug for at least 7 days prior to the gout flare and throughout the length of the trial.
6. Women of childbearing potential are excluded. Women not considered of childbearing potential must have one of the following documented in their study medical history:
1. Postmenopausal for at least 12 months prior to study;
2. Without a uterus and/or both ovaries; or
3. Bilateral tubal ligation at least six months prior to study enrollment.
Key Exclusion Criteria:
1. BMI of \>40kg/m2 at the time of screening
2. Subjects that have not changed their urate lowering therapy (ULT) in the 2 weeks prior to the start of the gout flare and who will remain on the same dose throughout the follow-up period of the trial.
3. Subjects who are contraindicated for the use of colchicine or whom are unable to take the SOC dose of 1.2mg followed by 0.6mg an hour later.
4. Subjects with rheumatoid arthritis, psoriatic arthritis, evidence/suspicion of infectious/septic arthritis, acute polyarticular gout (4 or more joints), with arthritis due to any cause other than gout that may confound any study assessments per Investigator discretion.
5. Subjects who have experienced \>2 gout flares per month, or \>12 attacks overall in the months prior to randomization.
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Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04130204
Study Brief:
Protocol Section:
NCT04130204