Gout Clinical Trial
Official title:
A Study to Assess a Direct Physical Measurement Method for Evaluation of Tophus Nodules in Subjects With Gout.
The purpose of this study is to determine the inter- and intra-rater reproducibility of direct physical measurement of tophus nodules in subjects with gout.
Gout is a chronic urate crystal deposition disorder. Left untreated, gout 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 greater than 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.1 As serum urate levels
increase beyond greater than 7.0 mg/dL, the risks for gouty arthritis or for renal calculi
increase.
Febuxostat is a 2-aryl-thiazole derivative chemically engineered as a novel xanthine
oxidase/dehydrogenase inhibitor. Febuxostat is being developed as an orally administered
agent for the management of hyperuricemia in patients with gout.
Subjects with palpable tophi >10 millimeters (mm) in length and width and as round as
possible will have the tophus measured on two separate visits by two different raters to
assess the inter- and intra-rater reproducibility of direct physical measurement.
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