Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guerbet
ClinicalTrials.gov Identifier:
NCT01523873
First received: January 26, 2012
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

The main purpose of this study is to prospectively assess the general safety profile of Dotarem


Condition
General Safety Profile of DOTAREM®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Post-marketing Study on the Safety and Efficacy of Dotarem® (SECURE Study)

Further study details as provided by Guerbet:

Primary Outcome Measures:
  • Frequency of Adverse Events [ Time Frame: During the time of usual follow-up post Dotarem administration, with an expected average of less than 24 hours ] [ Designated as safety issue: Yes ]

Enrollment: 35921
Study Start Date: November 2008
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All consecutive patients scheduled for a Dotarem®-enhanced MRI over a one year period at each participating radiological site

Criteria

Inclusion Criteria:

  • patient scheduled for a Dotarem®-enhanced MRI

Exclusion Criteria:

  • patient with a contra-indication to MR examination
  • patient with a contra-indication to Dotarem® injection as per local SPC
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01523873

Locations
France
Guerbet
Roissy CdG, France, 95943
Sponsors and Collaborators
Guerbet
  More Information

No publications provided

Responsible Party: Guerbet
ClinicalTrials.gov Identifier: NCT01523873     History of Changes
Other Study ID Numbers: DGD-55-001
Study First Received: January 26, 2012
Last Updated: October 31, 2013
Health Authority: Argentina: Ministry of Health
Argentina: Ethics Commitee
China: Ethics Committee
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Conseil National de l'Ordre des Médecins
France: The Commission nationale de l’informatique et des libertés
Germany: Federal Institute for Drugs and Medical Devices
India: Institutional Review Board
Italy: Ethics Committee
Saudi Arabia: Ethics Committee
Spain: Ethics Committee
Spain: Spanish Agency of Medicines

ClinicalTrials.gov processed this record on April 16, 2014