- Subject meets the diagnosis of gout as per the American Rheumatism Association
Criteria for the Classification of acute Arthritis of Primary Gout.
- Subjects taking urate lowering therapy at the time of screening must be willing to
discontinue their prior urate lowering therapy from the time of Screening Visit 1
until completion of the study period Day 16.
- Subjects taking urate lowering therapy at the time of screening must have a serum
urate level of >= 8.0 mg/dL at time of the second screening visit.
- Subjects NOT taking urate lowering therapy at the time of screening must have a serum
urate level of >= 8.0 mg/dL at both screening visits 1 and 2.
- Positive medical history or current evidence of medical or psychiatric
condition/disease, or ECG or laboratory abnormality that may increase the risk
associated with study participation or investigational product administration or may
interfere with the interpretation of study results and, in the judgment of the
Investigator, would make the subject inappropriate for entry into this study.
- Chronic kidney disease classified as moderate or severe (Clinical Practice Guideline,
National Kidney Foundation)12; with GFR Cockcroft-Gault equation.
- Subjects with current tophaceous gout.
- Gout flare that has not resolved for at least 2 weeks prior to randomization.