A RANDOMIZED DOUBLE-BLIND PARALLELL GROUP CLINICAL STUDY OF XENETIX 300 VERSUS VISIPAQUE 270 IN MULTISLICE CT PEDIATRIC INDICATIONS - PEDIATRIC MSCT
- Conditions
- Patients requiring MSCT with contrast medium injection for diagnosis
- Registration Number
- EUCTR2005-000664-51-AT
- Lead Sponsor
- GUERBET
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 142
- Child aged between 1 and 16 years, having an MSCT with contrast product injection planned
- Patient planned for a blood test in the 24 hours preceding the scan
- Female patient with child bearing potential with contracetion or who has a negative BetaHCG test
- Parents (and the child if aged over 12 years) having given their consent to participate in the study
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Patients who has received diuretic or biguanide treatment during 48 hours preceding the MSCT
- Patients having received an iodinated contrast agent during the 48 hours preceding the MSCT
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the equivalence of Xenetix 300 and Visipaque 270 in terms of renal tolerance when injected for MSCT in pediatric indications;Secondary Objective: To compare the two agents in terms of clinical safety and global imaging efficacy in pediatric MSCT;Primary end point(s): Calculation and assessment of the creatinine clearance according to Schwartz's formula, within 24 hours before the contrast medium administration and 72 +/- 12 hours after the contrast medium administration
- Secondary Outcome Measures
Name Time Method