Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout

Exclusion Criteria

• •1. Has received any investigational compound within 30 days prior to Screening.
• •2. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
• •3. Is breastfeeding or pregnant.
• •4. Has secondary hyperuricemia (eg, due to myeloproliferative disorder).
• •5. Has a history of xanthinuria.
• •6. Has received ULT (ie, allopurinol, probenecid, etc.) within 20 days prior to Day 1/Randomization Visit.
• •7. Has a known hypersensitivity to febuxostat or any components of their formulation; has a known hypersensitivity to naproxen, any other nonsteroidal anti-inflammatory drug (NSAID), aspirin, lansoprazole, colchicine or any components in their formulation.
• •8. Has active peptic ulcer disease.
• •9. Has a history of cancer (other than basal cell carcinoma of the skin) within 5 years prior to the Screening Visit.
• •10. Has alanine aminotransferase (ALT) and aspartate aminotransferase (AST) values \>2 x the upper limit of normal (ULN).
• •11. Has rheumatoid arthritis which requires treatment.
• •12. Has a significant medical condition and/or conditions that would interfere with the treatment, safety, or compliance with the protocol.
• •13. Has experienced a myocardial infarction (MI), stroke, hospitalized unstable angina, cardiac or cerebrovascular revascularization procedure or hospitalized transient ischemic attack (TIA) - except in participants who have severe renal impairment.
• •14. Participants with severe renal impairment had a MI or stroke within 90 days prior to initial screening visit or has a MI or stroke during the screening period prior to Day 1/Randomization Visit.
• •15. Participant consumes \>14 alcoholic beverages/week. Has a history of alcoholism or illicit drug abuse within 5 years.
• •16. Has participated in another investigational study within the 30 days prior to the Screening Visit.
• •17. Has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus.
• •18. Is required to take excluded medications.