Trials / Completed
CompletedNCT03048006
Post-marketing Surveillance Study for Evaluation of Dotarem Safety
Evaluation of Dotarem Safety
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 44,456 (actual)
- Sponsor
- Guerbet · Industry
- Sex
- All
- Age
- 100 Years
- Healthy volunteers
- Accepted
Summary
Guerbet conducted a non-interventional post-marketing surveillance study on its Magnetic Resonance Imaging (MRI) contrast agent Dotarem (gadoteric acid/gadoterate meglumine). The aim of this study, which was conducted in accordance with section 67, paragraph 6 of the German drug regulation, Arzneimittelgesetz, was to gain additional insights into the diagnostic efficacy, reliability and safety of Dotarem in routine practice using the most up-to-date MRI techniques and application methods.
Detailed description
Diagnostic efficacy was assessed by the following endpoints: diagnostic value ("yes"/"no") and imaging quality (5-step scale from "excellent" to "very poor"). Safety was evaluated on the basis of the frequency and seriousness of adverse events that occurred following Dotarem injection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | MRI with Dotarem |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2013-12-01
- Completion
- 2013-12-01
- First posted
- 2017-02-09
- Last updated
- 2017-05-02
- Results posted
- 2017-05-02
Source: ClinicalTrials.gov record NCT03048006. Inclusion in this directory is not an endorsement.