Gout Clinical Trial
Official title:
Phase II, Dose-Response, Safety and Efficacy Study of Oral TMX-67 in Subjects With Gout.
The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in reducing serum urate levels in subjects with gout.
Gout is a chronic urate crystal deposition disorder, which if left untreated may result in
progressive disease characterized by joint and bone destruction from tophaceous deposits and
renal impairment due to gouty nephropathy. Hyperuricemia, defined as a serum urate
concentration of >7.0 milligrams per deciliter (mg/dL), is the underlying metabolic
aberration leading to urate crystal deposition in gout. Gout has several clinical
presentations, including: recurrent acute attacks of inflammatory arthritis; deposition of
monosodium urate monohydrate crystals in joints, bones and even parenchymal organs
(tophaceous gout); renal impairment; and uric acid nephrolithiasis. As serum urate levels
increase beyond >7.0 mg/dL, the risks for gouty arthritis or for renal calculi increase.
Currently allopurinol is the only xanthine oxidase inhibitor available. Allopurinol is the
agent of choice for reduction of serum urate levels in patients with: uric acid
overproduction; unresponsive or intolerant to uricosuric agents; impaired renal function;
uric acid urolithiasis; or tophi.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic
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