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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
  Purpose

This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications.


Condition Intervention Phase
Diagnostic Imaging
Drug: Xenetix
Drug: Visipaque
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Guerbet:

Primary Outcome Measures:
  • 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


Enrollment: 145
Study Start Date: May 2006
Study Completion Date: June 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Year to 16 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347022

Locations
France
CHU Charles Nicolle
Rouen, France, 76031
Sponsors and Collaborators
Guerbet
Investigators
Study Chair: Corinne Dubourdieu, PhD Guerbet
  More Information

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

Keywords provided by Guerbet:
Multislice computed tomography (MSCT)indications

Additional relevant MeSH terms:
Iobitridol
Iodixanol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2014