Clinical trial NCT00175006: Validation Study of Physical Measurement of Tophi
Official title: A Study to Assess a Direct Physical Measurement Method for Evaluation of Tophus Nodules in Subjects With Gout.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gout
Keywords: Hyperuricemia
Tophi
Tophus
Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with palpable tophi \>10mm 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Must have at least 1 palpable gouty tophus nodule in the foot/ankle, hand/wrist, or elbow, confirmed as gouty by prior diagnosis according to ACR criteria.
* The tophus must be solid, round, non-tender, intact, and larger than 10mm in both length and width.
* Joints nearest and immediately adjacent to the selected tophus must not be acutely inflamed.
* Must be on stable treatment for gout with no medication changes in the past 30 days.

Exclusion Criteria:

* Must be able to return to the clinical site within 10 days.
* Must not have allergy to ink.

Primary outcomes:
measure: Average Percent Difference in Area Between Visits
timeFrame: Visit 1 (Day 1) and Visit 2 (Days 6-11)
measure: Average Percent Difference in Area Between Raters
timeFrame: Visit 1 (Day 1 ) and Visit 2 (Day 6-11)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Schumacher HR Jr, Becker MA, Palo WA, Streit J, MacDonald PA, Joseph-Ridge N. Tophaceous gout: quantitative evaluation by direct physical measurement. J Rheumatol. 2005 Dec;32(12):2368-72.