A Clinical Study of Xenetix 300 in Multislice Computed Tomography (CT) Pediatric Indications
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ClinicalTrials.gov Identifier: NCT00347022 |
Recruitment Status
:
Completed
First Posted
: July 4, 2006
Results First Posted
: April 9, 2013
Last Update Posted
: April 9, 2013
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Sponsor:
Guerbet
Information provided by (Responsible Party):
Guerbet
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Tracking Information | ||||
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First Submitted Date ICMJE | June 30, 2006 | |||
First Posted Date ICMJE | July 4, 2006 | |||
Results First Submitted Date | December 23, 2011 | |||
Results First Posted Date | April 9, 2013 | |||
Last Update Posted Date | April 9, 2013 | |||
Study Start Date ICMJE | May 2006 | |||
Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Creatinine Clearance [ Time Frame: between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration ] The variation of creatinine clearance before and after the product injection was measured
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Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | Complete list of historical versions of study NCT00347022 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Clinical Study of Xenetix 300 in Multislice Computed Tomography (CT) Pediatric Indications | |||
Official Title ICMJE | Not Provided | |||
Brief Summary | This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
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Condition ICMJE | Diagnostic Imaging | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
145 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date | June 2009 | |||
Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 1 Year to 16 Years (Child) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00347022 | |||
Other Study ID Numbers ICMJE | ISO-44-008 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Guerbet | |||
Study Sponsor ICMJE | Guerbet | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Guerbet | |||
Verification Date | April 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |