Validation Study of Physical Measurement of Tophi

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00175006
First received: September 12, 2005
Last updated: July 22, 2010
Last verified: July 2010

September 12, 2005
July 22, 2010
November 2002
January 2003   (final data collection date for primary outcome measure)
  • Average Percent Difference in Area Between Visits [ Time Frame: Visit 1 (Day 1) and Visit 2 (Days 6-11) ] [ Designated as safety issue: No ]
    The rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using average percent difference, calculated as absolute difference of Visits 1 and 2 divided by the average of Visits 1 and 2 for the same tophus, pooled across raters.
  • Average Percent Difference in Area Between Raters [ Time Frame: Visit 1 (Day 1 ) and Visit 2 (Day 6-11) ] [ Designated as safety issue: No ]
    Each rater measured length and width (mm) of the tophus at 2 visits separated by no more than 10 days. Area of the tophus was summarized using the average percent difference, calculated as the absolute difference of Raters 1 and 2 divided by the average of Raters 1 and 2 for the same tophus, pooled across visits.
Not Provided
Complete list of historical versions of study NCT00175006 on ClinicalTrials.gov Archive Site
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Validation Study of Physical Measurement of Tophi
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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

None taken or retained

Non-Probability Sample

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.

Gout
Other: Measurement of Tophi to validate procedure
Intra- and Inter-rater Reproducibility measurements of the area (in mm2) of each tophus nodule.
Tophi Participants
Intervention: Other: Measurement of Tophi to validate procedure
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
January 2003
January 2003   (final data collection date for primary outcome measure)

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.
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00175006
C02-019, U1111-1114-1944
No
Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
Takeda
Not Provided
Study Director: Medical Director Takeda
Takeda
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP