Clinical trial: Allopurinol Outcome Study (NCT01391325)

Eligibility criteria:
Inclusion Criteria:

          -  Meets the diagnosis of gout according to the American Rheumatism Association (ARA)
             Criteria for the Classification of Acute Arthritis of Primary Gout.

          -  Not on a urate lowering therapy (ULT) must have an sUA level ≥ 8.0 mg/dL at screening.

          -  If on concomitant ULT must have an sUA level ≥ 6.5 mg/dL at screening.

          -  Must have had at least 2 gout flares in the past year.

        Exclusion Criteria:

          -  Consumption of more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of
             wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).

          -  History or suspicion of drug abuse.

          -  History of autoimmune disease requiring systemic treatment.

          -  Known or suspected human immunodeficiency virus (HIV), hepatitis C antibody (HCV), or
             hepatitis B antibody (HBsAg) infection.

          -  History of malignancy within the previous 5 years (with the exception of nonmelanoma
             skin cancer that has been treated with no evidence of recurrence, treated cervical
             dysplasia or treated in situ Grade 1 cervical cancer).

          -  Myocardial infarction, unstable angina, New York Heart Association (NYHA) class III or
             IV heart failure, or stroke within the last 12 months.

          -  Uncontrolled hypertension (systolic pressure above 160 mm Hg or diastolic pressure
             above 95 mm Hg).

          -  Estimated creatinine clearance < 30 mL/min by Cockcroft-Gault formula.

          -  Kidney or other organ transplant.

          -  Active peptic ulcer disease requiring treatment.

          -  History of xanthinuria, active liver disease, or hepatic dysfunction.

          -  If unable to take gout flare prophylaxis of either colchicine or nonsteroidal
             anti-inflammatory drugs (NSAIDs) due to contraindication (e.g. toxicity, renal
             function, use of contraindicated medications).

          -  Known hypersensitivity or allergy to allopurinol.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 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