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Magnetic Resonance Imaging in Subjects With Gouty Tophi

This study has been completed.
Sponsor:
Information provided by:
Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:
NCT00174954
First received: September 12, 2005
Last updated: July 22, 2010
Last verified: July 2010
History of Changes
Results First Received: March 12, 2009  
Study Type: Observational
Study Design: Time Perspective: Prospective
Conditions: Hyperuricemia
Gout
Intervention: Procedure: MRI

  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 6 study centers from 07 March 2002 to 28 January 2003.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects with palpable gouty tophi in select anatomical sites underwent pre- and post-contrast Magnetic Resonance Imaging (MRI)

Reporting Groups
  Description
Palpable Gouty Tophi Subjects Volumes/measurements of tophi determined by serial MRI

Participant Flow:   Overall Study
    Palpable Gouty Tophi Subjects  
STARTED     32  
COMPLETED     28  
NOT COMPLETED     4  
Adverse Event                 2  
No tophi found in MRI                 1  
Physician Decision                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Palpable Gouty Tophi Subjects Volumes/measurements of tophi determined by serial MRI

Baseline Measures
    Palpable Gouty Tophi Subjects  
Number of Participants  
[units: participants]
 		  32  
Age  
[units: years]
Mean ± Standard Deviation 		  61.2  ± 15.5  
Age, Customized  
[units: participants]
 		 
18 years to 35 years     1  
36 years to 50 years     9  
51 years to 65 years     7  
66 years to 85 years     13  
>85 years     2  
Gender  
[units: participants]
 		 
Female     2  
Male     30  
Race/Ethnicity  
[units: participants]
 		 
White     22  
Black or African American     9  
Hispanic     1  



  Outcome Measures
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1.  Primary:   Measurement of Tophi by MRI - Difference in Volument Between Visits   [ Time Frame: Visit 1 (Day 1) and Visit 2 (Days 6-11) ]
  Show Outcome Measure 1

2.  Primary:   Measurement of Tophi by MRI - Difference in Volume Between Readers   [ Time Frame: Visit 1 (Day 1) and Visit 2 (Days 6-11) ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


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: NCT00174954     History of Changes
Other Study ID Numbers: TMX-01-013, U1111-1113-9856
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