Clinical trial: Study to Evaluate sUA Lowering Activity, Safety and Efficacy of Oral Ulodesine Added to Allopurinol (NCT01265264)

Eligibility criteria:
Inclusion Criteria:

          -  Age ≥ 18 to < 70 years

          -  Baseline sUA ≥ 6.0 mg/dL after at least 2 weeks of treatment on a stable 300 mg dose
             of allopurinol

          -  Documented diagnosis of gout according to the American Rheumatism Association
             --Preliminary Criteria for the Diagnosis of Gout

          -  Be willing and able to take colchicine 0.6 mg per day or naproxen 220-250 mg twice
             daily as prophylaxis for gout flares and, if needed, a single daily dose of a proton
             pump inhibitor to prevent gastrointestinal discomfort

          -  Female participants must:

               -  Be sexually abstinent

               -  Be surgically sterile

               -  Be postmenopausal or on stable contraception

          -  Male participants must:

               -  Be sexually abstinent

               -  Be > 1 year post-vasectomy

               -  Using condoms with spermicide with partners meeting female requirements

        Exclusion Criteria:

          -  Unable to tolerate 300 mg allopurinol

          -  Unable to tolerate both colchicine 0.6 mg per day and naproxen 220-250 mg twice daily

          -  Prior participation in a clinical study with BCX4208

          -  Gout flare during the Screening Period that is resolved for less than 2 weeks prior to
             first treatment with BCX4208 or placebo (exclusive of chronic synovitis/ arthritis)

          -  Unstable angina, symptomatic arrhythmia, signs or symptoms compatible with New York
             Heart Association Class III or Class IV heart failure, history of long QT syndrome, or
             QTc interval < 350 msec or > 475 msec

          -  Poorly controlled hypertension (SBP > 160 mmHg or DBP > 100 mmHG at Screening or
             Baseline)

          -  Moderate or severe renal impairment and/or calculated creatinine clearance of < 60
             mL/min(Cockroft-Gault method)

          -  Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values > 2.0 x ULN

          -  CD4+ cell counts by flow cytometry < 500 cells/mm3

          -  Hemoglobin < 10 g/dL or > 18 g/dL males or < 10 g/dL or > 17 g/dL females White blood
             cell count < 3.7 x 109/L or > 11 x 109/L

          -  Female subjects who are pregnant, breastfeeding, or planning a pregnancy within the
             next 4 months

          -  Positive serology for hepatitis B surface antigen or hepatitis C or HIV type 1

          -  Immunocompromised or on systemic immunosuppressive medications or antirheumatic drugs
             (including anakinra and adrenocorticotropic hormone)from Screening to Day 92

          -  Azathioprine or 6-mercaptopurine within 14 days of first dose of allopurinol
             Hydrochlorothiazide in doses > 50 mg per day from Screening to Day 92

          -  Use of herbal/dietary supplements Screening to Day 92

          -  Recipient of any live or attenuated vaccine within 6 weeks of Screening

          -  Uric acid-lowering drugs other than allopurinol from Screening to Day 92 Systemic
             corticosteroids within 4 weeks prior to Day 1 (this does not include pulmonary or
             nasal inhaler containing corticosteroids, ophthalmic corticosteroids, joint
             injections, or low potency topical steroids)

          -  Investigational drug within 30 days prior to signing the ICF for this study

          -  Clinically significant and relevant drug allergies

          -  Chronic or recurrent infections (≥ 3 infections at the same site within 12 months)

          -  Cancer within 12 months-Except non-melanomatous localized skin cancer or completely
             excised and cured carcinoma-in-situ of uterine cervix or subjects who were previously
             treated for prostate or breast cancer if they currently are stable and have not been
             on chemo therapy within the last year prior to screening.

          -  Alcohol or drug abuse within 12 months of signing the ICF, or current substance
             dependence or abuse

          -  Other medical conditions which, in the opinion of the PI, would jeopardize the safety
             of the study subject or impact the validity of the study results.
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 69 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