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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
Sponsor:
Information provided by (Responsible Party):
Guerbet

Study Description
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Brief Summary:
This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications.

Condition or disease Intervention/treatment Phase
Diagnostic Imaging Drug: Xenetix Drug: Visipaque Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Study Start Date : May 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

Arms and Interventions
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Arm Intervention/treatment
Experimental: Xenetix
The patient receive one injection of Xenetix 300 (300 mg of iodine/ml)
 Drug: Xenetix
300 mg of iodine/ml
Active Comparator: Visipaque
The patient receive one injection of Visipaque 270 (270 mg of iodine/ml)
 Drug: Visipaque
270 mg of iodine/ml


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00347022


Locations
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France
CHU Charles Nicolle
Rouen, France, 76031
Sponsors and Collaborators
Guerbet
Investigators
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Study Chair: Corinne Dubourdieu, PhD Guerbet
More Information
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Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT00347022    
Other Study ID Numbers: ISO-44-008
First Posted: July 4, 2006    Key Record Dates
Results First Posted: April 9, 2013
Last Update Posted: April 9, 2013
Last Verified: April 2013
Keywords provided by Guerbet:
Multislice computed tomography (MSCT)indications