Clinical trial: Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors (NCT01508702)

Eligibility criteria:
Inclusion Criteria:

          -  Subject is able to understand the study procedures, the risks involved and willing to
             provide written informed consent before the first study related activity.

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

          -  Subject has an sUA level ≥ 6.5 mg/dL at the Screening and Day -7 Visits.

          -  Subject must be able to take gout flare prophylaxis with colchicine or NSAID
             (including Cox-2 selective NSAID) ± PPI.

          -  Subject has a history (either by medical record or subject interview) of intolerance
             or a contraindication to either allopurinol or febuxostat.

          -  Body mass index (BMI) < 45 kg/m2

        Exclusion Criteria:

          -  Subject who is taking any other approved urate-lowering medication that is indicated
             for the treatment of gout at the Screening Visit.

          -  Subject with a documented history or suspicion of kidney stones.

          -  Subject who is pregnant or breastfeeding.

          -  Subject who consumes 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).

          -  Subject with a history or suspicion of drug abuse within the past 5 years.

          -  Subject that requires or may require systemic immunosuppressive or immunomodulatory
             treatment.

          -  Subject with a known or suspected human immunodeficiency virus (HIV) infection.

          -  Subject with a positive test for active hepatitis B or hepatitis C infection.

          -  Subject with a history of malignancy within the previous 5 years with the exception of
             non-melanoma skin cancer that has been treated with no evidence of recurrence, treated
             cervical dysplasia or treated in situ Grade 1 cervical cancer.

          -  Subject within the last 12 months with: unstable angina, New York Heart Association
             class III or IV heart failure, myocardial infarction, stroke, or deep venous
             thrombosis; or subjects currently receiving anticoagulants.

          -  Subject with uncontrolled hypertension.

          -  Subject with an estimated creatinine clearance < 30 mL/min.

          -  Subject with active peptic ulcer disease requiring treatment.

          -  Subject with active liver disease, or hepatic dysfunction.

          -  Subject receiving chronic treatment with more than 325 mg salicylates per day.

          -  Subject taking valpromide, progabide, or valproic acid.

          -  Subject who has received an investigational therapy within 8 weeks or 5 half-lives
             (whichever is longer) prior to the Screening Visit.

          -  Subject with any other medical or psychological condition, which in the opinion of the
             Investigator and/or Medical Monitor, might create undue risk to the subject or
             interfere with the subject's ability to comply with the protocol requirements, or to
             complete the study.
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