Trial Outcomes & Findings for Validation Study of Physical Measurement of Tophi (NCT NCT00175006)
NCT ID: NCT00175006
Last Updated: 2010-07-27
Results Overview
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.
COMPLETED
13 participants
Visit 1 (Day 1) and Visit 2 (Days 6-11)
2010-07-27
Participant Flow
Subjects were enrolled at 2 study sites in the United States from 19 November 2002 to 09 January 2003.
Participant milestones
| Measure |
Tophi Participants
Participants with palpable tophi \>10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Validation Study of Physical Measurement of Tophi
Baseline characteristics by cohort
| Measure |
Tophi Participants
n=13 Participants
Participants with palpable tophi \>10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
|
|---|---|
|
Age Continuous
|
60.5 years
STANDARD_DEVIATION 14.1 • n=93 Participants
|
|
Age, Customized
18 years to 35 years
|
0 participants
n=93 Participants
|
|
Age, Customized
36 years to 50 years
|
2 participants
n=93 Participants
|
|
Age, Customized
51 years to 65 years
|
6 participants
n=93 Participants
|
|
Age, Customized
66 years to 85 years
|
5 participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
5 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (Day 1) and Visit 2 (Days 6-11)Population: Measurements of 52 tophi were obtained at 2 separate visits separated by no more than 10 days from the 13 subjects enrolled. Change in tophus size over 10 days was not expected.
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.
Outcome measures
| Measure |
Tophi Participants
n=13 Participants
Participants with palpable tophi \>10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
|
|---|---|
|
Average Percent Difference in Area Between Visits
Average Percent Difference
|
29 mm²
Standard Deviation 33
|
PRIMARY outcome
Timeframe: Visit 1 (Day 1 ) and Visit 2 (Day 6-11)Population: Measurements of 52 tophi were obtained at 2 separate visits separated by no more than 10 days from the 13 subjects enrolled.
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.
Outcome measures
| Measure |
Tophi Participants
n=13 Participants
Participants with palpable tophi \>10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
|
|---|---|
|
Average Percent Difference in Area Between Raters
Average Percent Difference
|
32 mm²
Standard Deviation 27
|
Adverse Events
Tophi Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sr. VP, Clinical Science
Takeda Global Research and Development Center, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER