Trial Condition(s):
Hypersensitivity
A study to learn more about the safety of Ultravist in children and in the elderly
Bayer Identifier:
21494
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
Ultravist is an iodine-based contrast agent that helps to make medical imaging scans clearer. It is also called iopromide, and it is available for doctors to give patients before they have scans. Even after a treatment or substance has been approved for use, researchers continue to study it to learn more about its safety.
Researchers have done studies on the safety of Ultravist, but they want to learn more about specific medical problems called hypersensitivity reactions (HSRs). These are undesirable immune system reactions to the study drug. In this study, the researchers will compare the risk of HSRs in children and in the elderly to the risk of HSRs in middle aged adults.
The researchers will look at information about medical problems that happened in people in 4 other studies. These studies are called PMS I, IMAGE, TRUST, and Ultravist in CT. A total of about 139,000 people will be included in this study.
All of the people in the earlier 4 studies received Ultravist as an injection into the vein or artery before having a scan. In this study, the researchers will compare the number of children, middle aged adults, and elderly patients who had HSRs after receiving Ultravist.
Inclusion Criteria
- We included patients of all age groups which were referred to a iodine-based contrast-enhanced procedure of any body part.
Exclusion Criteria
- Patients with missing age, sex or who did not receive Ultravist 300 or 370 were excluded.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Four company sponsored non-interventional studies with iopromide Berlin, Germany | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Safety profile of Ultravist in children and elderly (UV Age)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
4
Primary Outcome
- Number of participants with hypersensitivity reactions to Ultravist in children and elderly patients compared to middle-age adultsTimeframe: Analysis will be done in 2 months
Secondary Outcome
- Profile of HSRs (hypersensitivity reactions) in the three age groupsTimeframe: Analysis will be done in 2 months
- General reported ADR (adverse drug reactions) profile in the three age groupsTimeframe: Analysis will be done in 2 months
Additional Information
Not Available
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