Gout Clinical Trial
Official title:
A Phase 3, Randomized, Multicenter, Double-Blind, Allopurinol-Controlled Study Assessing the Efficacy and Safety of Oral Febuxostat in Subjects With Gout.
The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily (QD), to allopurinol in subjects with hyperuricemia and gout.
Renal impairment is common in subjects with gout, with the prevalence ranging from 50% to
70%. This population represents an unmet medical need as uricosuric drugs are
contraindicated in these patients, and the only available treatment, allopurinol, may have
to be dose reduced to avoid overt side effects.
Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as
an orally administered agent for management of hyperuricemia in patients with gout.
Treatment duration will be 6 months.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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