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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00347022
Other study ID # ISO-44-008
Secondary ID
Status Completed
Phase Phase 4
First received June 30, 2006
Last updated April 8, 2013
Start date May 2006
Est. completion date June 2009

Study information

Verified date April 2013
Source Guerbet
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)European Union: European Medicines Agency
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 145
Est. completion date June 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 16 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Drug:
Xenetix
300 mg of iodine/ml
Visipaque
270 mg of iodine/ml

Locations

Country Name City State
France CHU Charles Nicolle Rouen

Sponsors (1)

Lead Sponsor Collaborator
Guerbet

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Creatinine Clearance The variation of creatinine clearance before and after the product injection was measured between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration Yes
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