Clinical trial: RDEA3170 Monotherapy in Subjects With Gout (NCT01927198)

Eligibility criteria:
Inclusion Criteria:

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

          -  Subject has a serum urate level ≥ 6.5 mg/dL and ≤ 10.0 mg/dL during the Screening
             Period.

          -  Subject has a body mass index < 40 kg/m2.

        Exclusion Criteria:

          -  Subject is pregnant or breastfeeding. Subject 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 has a history or suspicion of kidney stones.

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

          -  Subject has a history of symptomatic myositis/myopathy or rhabdomyolysis.

          -  Subject has a known or suspected human immunodeficiency virus infection.

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

          -  Subject has 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 has a QT interval corrected for heart rate according to Fridericia's formula >
             450 msec during the Screening Period, confirmed by a repeat assessment.

          -  Subject has uncontrolled hypertension.

          -  Subject has an estimated creatinine clearance < 60 mL/min.

          -  Subject has an alkaline phosphatase > 2.0 x upper limit of normal during the Screening
             Period.

          -  Subject has active liver disease or impaired hepatic function.

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

          -  Subject has a medical condition that requires or may require systemic
             immunosuppressive (eg, chronic low-dose oral prednisone) or immunomodulatory
             treatment.

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

          -  Subject is receiving strong or moderate CYP3A inhibitors, p-glycoprotein inhibitors,
             or digoxin.

          -  Subject received any strong enzyme- inducing drug or product (eg, rifampin, rifabutin,
             phenytoin, phenobarbital, St. John's Wort) within 2 months prior to Day 1 or refuses
             to refrain from taking these medications until the end of the study.

          -  Subject received an investigational therapy within 30 days or 5 half-lives (whichever
             is longer) prior to the Screening Period.

          -  Subject has 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 70 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? 0