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
Results First Received: March 12, 2009  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Gout
Intervention: Other: Measurement of Tophi to validate procedure

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were enrolled at 2 study sites in the United States from 19 November 2002 to 09 January 2003.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Tophi Participants  
STARTED     13  
COMPLETED     13  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Baseline Measures
    Tophi Participants  
Number of Participants  
[units: participants]
  13  
Age  
[units: years]
Mean ± Standard Deviation
  60.5  ± 14.1  
Age, Customized  
[units: participants]
 
18 years to 35 years     0  
36 years to 50 years     2  
51 years to 65 years     6  
66 years to 85 years     5  
Gender  
[units: participants]
 
Female     2  
Male     11  
Race/Ethnicity, Customized  
[units: participants]
 
White     5  
Black or African American     7  
Asian     1  



  Outcome Measures
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1.  Primary:   Average Percent Difference in Area Between Visits   [ Time Frame: Visit 1 (Day 1) and Visit 2 (Days 6-11) ]

2.  Primary:   Average Percent Difference in Area Between Raters   [ Time Frame: Visit 1 (Day 1 ) and Visit 2 (Day 6-11) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


Publications of Results:

Responsible Party: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00175006     History of Changes
Other Study ID Numbers: C02-019, U1111-1114-1944
Study First Received: September 12, 2005
Results First Received: March 12, 2009
Last Updated: July 22, 2010
Health Authority: United States: Food and Drug Administration