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A Clinical Study of Xenetix 300 in Multislice Computed Tomography (CT) Pediatric Indications

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT00347022
First received: June 30, 2006
Last updated: April 8, 2013
Last verified: April 2013
Results First Received: December 23, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition: Diagnostic Imaging
Interventions: Drug: Xenetix
Drug: Visipaque

  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
First patient first visit = 30/05/2006 Last patient last visit = 14/04/2009 Location = radiological department (Hospitals)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Any patient having a creatinine clearance < 60ml/min/1.73m² at time of baseline blood sample and/or positive beta HCG (Human Chorionic Gonadotropin) within 48h before contrast medium administration was considered as immediate withdrawal from trial

Reporting Groups
  Description
Xenetix Patient will receive one injection of Xenetix 300
Visipaque Patient will receive one injection of Visipaque 270

Participant Flow:   Overall Study
    Xenetix     Visipaque  
STARTED     74     71  
COMPLETED     62     66  
NOT COMPLETED     12     5  



  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
Xenetix Patient will be injected with Xenetix 300
Visipaque Patient will be injected with Visipaque 270
Total Total of all reporting groups

Baseline Measures
    Xenetix     Visipaque     Total  
Number of Participants  
[units: participants]
  74     71     145  
Age  
[units: participants]
     
<=18 years     74     71     145  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  8.7  ± 4.8     8.1  ± 4.7     8.4  ± 4.7  
Gender  
[units: participants]
     
Female     31     28     59  
Male     43     43     86  
Region of Enrollment  
[units: participants]
     
France     59     56     115  
Austria     15     15     30  



  Outcome Measures

1.  Primary:   Creatinine Clearance   [ Time Frame: between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration ]


  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
No text entered.


  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: Corinne DUBOURDIEU
Organization: GUERBET
phone: +33.1.45.91.50.00
e-mail: corinne.dubourdieu@guerbet-group.com


No publications provided


Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT00347022     History of Changes
Other Study ID Numbers: ISO-44-008
Study First Received: June 30, 2006
Results First Received: December 23, 2011
Last Updated: April 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
European Union: European Medicines Agency