Validation Study of Physical Measurement of Tophi - Full Text View

Sponsored by:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00175006

Purpose

The objective of this study was to assess the inter- and intra-rater reproducibility of direct physical measurement of tophus nodules in subjects with gout. A standard tape measure was used to measure area.

Condition	Intervention	Phase
Hyperuricemia Gout	Other: Measurement of Tophi to validate procedure	Phase II

MedlinePlus related topics: Gout

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Study to Assess a Direct Physical Measurement Method for Evaluation of Tophus Nodules in Subjects With Gout.

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Biospecimen Retention: None Retained

Biospecimen Description:

None taken or retained

Enrollment:	13
Study Start Date:	November 2002
Study Completion Date:	January 2003
Primary Completion Date:	January 2003 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Group 1	Other: Measurement of Tophi to validate procedure Measurement of Tophi to validate procedure.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175006

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Chair:

Medical Director

Takeda Global Research & Development Center, Inc.

More Information

Publications of Results:

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.

Responsible Party:	Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science )
Study ID Numbers:	C02-019
Study First Received:	September 12, 2005
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00175006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:

Gout
Tophi
Tophus

Study placed in the following topic categories:

Metabolism, Inborn Errors
Metabolic Diseases
Genetic Diseases, Inborn
Musculoskeletal Diseases
Joint Diseases
Arthritis

Hyperuricemia
Rheumatic Diseases
Metabolic disorder
Purine-Pyrimidine Metabolism, Inborn Errors
Gout

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009