Clinical trial: RDEA3170 and Febuxostat Combination Study in Gout Subjects (NCT02246673)

Eligibility criteria:
Inclusion Criteria:

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

          -  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.

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

          -  Screening serum urate level ≥ 8 mg/dL.

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

        Exclusion Criteria:

          -  Unable to take colchicine for gout flare prophylaxis.

          -  History or suspicion of kidney stones.

          -  Any gastrointestinal disorder that affects motility and/or absorption.

          -  Unstable angina, New York Heart Association class III or IV heart failure, ischemic
             heart disease, stroke, or deep venous thrombosis within 12 months prior to Day 1; or
             subject is currently receiving anticoagulants.

          -  Screening laboratory parameters that are outside the normal limits and are considered
             clinically significant by the Investigator.

          -  Estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula
             using ideal body weight during the Screening period.

          -  Taking losartan, fenofibrate, guaifenesin, or sodium-glucose linked transporter-2
             inhibitors; chronic and stable doses are permitted if doses are stable for at least 14
             days prior to study medication dosing.

          -  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.
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 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? 0