A Clinical Study of Xenetix 300 in Multislice Computed Tomography (CT) Pediatric Indications

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Diagnostic Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Xenetix

The patient receive one injection of Xenetix 300 (300 mg of iodine/ml)

Group Type EXPERIMENTAL

Xenetix

Intervention Type DRUG

300 mg of iodine/ml

Visipaque

The patient receive one injection of Visipaque 270 (270 mg of iodine/ml)

Group Type ACTIVE_COMPARATOR

Visipaque

Intervention Type DRUG

270 mg of iodine/ml

Interventions

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Xenetix

300 mg of iodine/ml

Intervention Type DRUG

Visipaque

270 mg of iodine/ml

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No