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

Tracking Information
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; (submitted: April 8, 2013)	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
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
Condition ICMJE	Diagnostic Imaging
Intervention ICMJE	Drug: Xenetix 300 mg of iodine/ml; Drug: Visipaque 270 mg of iodine/ml
Study Arms	Experimental: Xenetix The patient receive one injection of Xenetix 300 (300 mg of iodine/ml) Intervention: Drug: Xenetix; Active Comparator: Visipaque The patient receive one injection of Visipaque 270 (270 mg of iodine/ml) Intervention: Drug: Visipaque
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: April 8, 2013)	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: Child aged 1 year or above and 16 years or under; Patients with normal renal function (creatinine clearance > 60 ml/min/1.73 m2); Patient requiring MSCT with contrast medium injection for diagnosis; Patient who has a blood sample planned in the 24 hours preceding the MSCT scan; Female patient with childbearing potential must have effective contraception (contraceptive pill or intrauterine device), be surgically sterilized or blood beta human chorionic gonadotropin (ßHCG) will be tested prior to product injection.; Parent(s) of the patient (and child with sufficient intellectual maturity) provided his/her/their written informed consent for their child to participate in the trial.; Patient with national health insurance Exclusion Criteria: Patients who have received diuretic or biguanide treatment during the 48 hours preceding the MSCT scan.; Patient with known allergy to iodinated contrast agent.; Patient treated with nephrotoxic drugs within one week before first blood sample; Patients planned to either undergo surgery or receive chemotherapy within 72 hours post injection (ie: before the blood test 72 hours post injection); Patient received or planned to receive an iodinated contrast agent during 48 hours preceding the MSCT scan.; Breast feeding patient.; Pregnant patient.; Patient already included in this trial; Patient included in another clinical trial involving an investigational drug.; Patients whose degree of cooperation is incompatible with carrying out the study
Sex/Gender	Sexes Eligible for Study: All
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	Study Chair: Corinne Dubourdieu, PhD Guerbet
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