N/A
N=13
Validation Study of Physical Measurement of Tophi
Gout
Bottom Line
View on ClinicalTrials.gov: NCT00175006 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jul 2009
Primary outcome: Primary: Average Percent Difference in Area Between Visits — 29 mm²
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Measurement of Tophi to validate procedure (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Jan 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Percent Difference in Area Between Visits |
29 | — |
| PRIMARY Average Percent Difference in Area Between Raters |
32 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00175006). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.