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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
History of Changes

June 30, 2006
April 8, 2013
May 2006
April 2009   (final data collection date for primary outcome measure)
Creatinine Clearance [ Time Frame: between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration ] [ Designated as safety issue: Yes ]
The variation of creatinine clearance before and after the product injection was measured
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Complete list of historical versions of study NCT00347022 on ClinicalTrials.gov Archive Site
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A Clinical Study of Xenetix 300 in Multislice Computed Tomography (CT) Pediatric Indications
Not Provided

This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Diagnostic Imaging
  • Drug: Xenetix
    300 mg of iodine/ml
  • Drug: Visipaque
    270 mg of iodine/ml
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
June 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
1 Year to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00347022
ISO-44-008
Not Provided
Guerbet
Guerbet
Not Provided
Study Chair: Corinne Dubourdieu, PhD Guerbet
Guerbet
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP