Status:
COMPLETED
Validation Study of Physical Measurement of Tophi
Lead Sponsor:
Takeda
Conditions:
Gout
Eligibility:
All Genders
18-85 years
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 du...
Eligibility Criteria
Inclusion
- 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
- Must be able to return to the clinical site within 10 days.
- Must not have allergy to ink.
Key Trial Info
Start Date :
November 1 2002
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2003
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00175006
Start Date
November 1 2002
End Date
January 1 2003
Last Update
July 27 2010
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