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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2005-000664-51-GB |
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Date of registration:
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13/02/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A RANDOMIZED DOUBLE-BLIND PARALLELL GROUP CLINICAL STUDY OF XENETIX 300 VERSUS VISIPAQUE 270 IN MULTISLICE CT PEDIATRIC INDICATIONS - XENETIX 300 VS VISIPAQUE 270 IN MSCT IN CHILDREN
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Scientific title:
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A RANDOMIZED DOUBLE-BLIND PARALLELL GROUP CLINICAL STUDY OF XENETIX 300 VERSUS VISIPAQUE 270 IN MULTISLICE CT PEDIATRIC INDICATIONS - XENETIX 300 VS VISIPAQUE 270 IN MSCT IN CHILDREN |
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Date of first enrolment:
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26/04/2006 |
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Target sample size:
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142 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-000664-51 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
- 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 contraception or who has a negative BetaHCG test
- Parents (and child with sufficient intellectual maturity) 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
Exclusion criteria:
- Patients who have 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
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Patients requiring MSCT with contrast medium injection for diagnosis
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Intervention(s)
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Trade Name: XENETIX 300 MG I / ML
Product Name: XENETIX 300 MG I / ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IOBITRIDOL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 300-
Trade Name: VISIPAQUE 270 MG I / ML
Product Name: VISIPAQUE 270 MG I / ML
Pharmaceutical Form: Solution for injection
INN or Proposed INN: IODIXANOL
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 270-
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Primary Outcome(s)
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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
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Secondary Objective: To compare the two agents in terms of clinical safety and global imaging efficacy in pediatric MSCT
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Main Objective: To demonstrate the equivalence of Xenetix 300 and Visipaque 270 in terms of renal tolerance when injected for MSCT in pediatric indications
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Secondary ID(s)
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ISO-44-008
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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