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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Guerbet

ClinicalTrials.gov Identifier:

NCT00347022

First received: June 30, 2006

Last updated: April 8, 2013

Last verified: April 2013

History of Changes

Results First Received: December 23, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Diagnostic
Condition:	Diagnostic Imaging
Interventions:	Drug: Xenetix Drug: Visipaque

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient first visit = 30/05/2006 Last patient last visit = 14/04/2009 Location = radiological department (Hospitals)

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Any patient having a creatinine clearance < 60ml/min/1.73m² at time of baseline blood sample and/or positive beta HCG (Human Chorionic Gonadotropin) within 48h before contrast medium administration was considered as immediate withdrawal from trial

Reporting Groups

	Description
Xenetix	Patient will receive one injection of Xenetix 300
Visipaque	Patient will receive one injection of Visipaque 270

Participant Flow: Overall Study

	Xenetix	Visipaque
STARTED	74	71
COMPLETED	62	66
NOT COMPLETED	12	5

Baseline Characteristics

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Reporting Groups

	Description
Xenetix	Patient will be injected with Xenetix 300
Visipaque	Patient will be injected with Visipaque 270
Total	Total of all reporting groups

Baseline Measures

	Xenetix	Visipaque	Total
Number of Participants [units: participants]	74	71	145
Age [units: participants]
<=18 years	74	71	145
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	8.7 ± 4.8	8.1 ± 4.7	8.4 ± 4.7
Gender [units: participants]
Female	31	28	59
Male	43	43	86
Region of Enrollment [units: participants]
France	59	56	115
Austria	15	15	30

Outcome Measures

1. Primary:

Creatinine Clearance [ Time Frame: between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Draft of publication to be submitted by the coordinating investigator (no more than 6 months after getting study results) to sponsor and other investigators for review at least 1 month before the submission to the scientific review. Comments to be reviewed and approved by the coordinating investigator and sponsor. Each investigator agrees not to publish the comparison of the renal tolerance involving only the patients he/she has included.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Corinne DUBOURDIEU
Organization: GUERBET
phone: +33.1.45.91.50.00
e-mail: corinne.dubourdieu@guerbet-group.com

No publications provided

Responsible Party:	Guerbet
ClinicalTrials.gov Identifier:	NCT00347022 History of Changes
Other Study ID Numbers:	ISO-44-008
Study First Received:	June 30, 2006
Results First Received:	December 23, 2011
Last Updated:	April 8, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) European Union: European Medicines Agency

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