Clinical trial: RDEA3170 and Allopurinol Combination Study in Gout Subjects (NCT02279641)

Eligibility criteria:
Inclusion Criteria:

          -  Subject meets one or more criteria for the diagnosis of gout as per the American
             Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary
             Gout.

          -  Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 45
             kg/m2.

          -  Subject has a Screening serum urate level ≥ 8 mg/dL and ≤ 10 mg/dL

          -  Subject is free of any clinically significant disease or medical condition, per the
             Investigator's judgment.

        Exclusion Criteria:

          -  Subject is unable to take colchicine for gout flare prophylaxis.

          -  Subject has a history or suspicion of kidney stones.

          -  Subject has an estimated creatinine clearance < 60 mL/min calculated by the
             Cockcroft-Gault formula using ideal body weight at Screening prior to Day -2.

          -  Subject is on unstable doses of chronic medications. Subjects taking medications for
             chronic medical conditions must be on stable doses during the course of the study,
             including the Screening period. Dose adjustments are allowed if deemed medically
             necessary by the investigator and following discussion with the medical monitor

          -  Chronic and stable doses of losartan, fenofibrate, guaifenesin, and sodium-glucose
             linked transporter-2 inhibitors are permitted if the dose is stable for at least 14
             days prior to study medication dosing.

          -  Subject is unable or unwilling to comply with the study requirements or has a
             situation or condition that, in the opinion of the Investigator, may interfere with
             participation in the study.
Male
No healthy subjects accepted to join the trial.
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? Contradiction