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

NCT00347022 | Completed Phase 4 Results

• 1 other identifier: ISO-44-008
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diagnostic Imaging

Keywords

Multislice computed tomography (MSCT)indications

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Xenetix

EXPERIMENTAL

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

Drug: Xenetix

Visipaque

ACTIVE COMPARATOR

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

Drug: Visipaque

Interventions

Xenetix DRUG

300 mg of iodine/ml

Xenetix

Visipaque DRUG

270 mg of iodine/ml

Visipaque

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guerbet: lead

Study Sites (1)

CHU Charles Nicolle

Rouen, 76031, France

Location

MeSH Terms

Interventions

iobitridol; iodixanol

Results Point of Contact

• Title: Corinne DUBOURDIEU
• Organization: GUERBET

corinne.dubourdieu@guerbet-group.com

+33.1.45.91.50.00

Study Officials

• Corinne Dubourdieu, PhD

  Guerbet

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2006
• First Posted: July 4, 2006
• Study Start: May 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: June 1, 2009
• Last Updated: April 9, 2013
• Results First Posted: April 9, 2013

Record last verified: 2013-04

Locations

FR (1)