Clinical trial: Topical Application to Relieve Gout: Efficacy Trial & Safety (TARGETS) (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.

             -
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain.  The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint.  Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis.

Patient description (patient's own words): I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis.

Does the patient match the trial criteria? Entailment