check_circleStudy Completed

Hypersensitivity

Bayer Identifier:

21494

ClinicalTrials.gov Identifier:

NCT04605471

EudraCT Number:

Not Available

EU CT Number:

Not Available
A study to learn more about the safety of Ultravist in children and in the elderly

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.

Key Participants Requirements

Sex

All

Age

NaN - N/A
  • - We included patients of all age groups which were referred to a iodine-based contrast-enhanced procedure of any body part.
  • - Patients with missing age, sex or who did not receive Ultravist 300 or 370 were excluded.

Trial summary

Enrollment Goal
132850
Trial Dates
October 2020 - March 2021
Phase
Phase 4
Could I Receive a placebo
No
Products
Ultravist (Iopromide, BAY86-4877)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Four company sponsored non-interventional studies with iopromideBerlin, Germany

Primary Outcome

  • Number of participants with hypersensitivity reactions to Ultravist in children and elderly patients compared to middle-age adults
    date_rangeTime Frame:
    Analysis will be done in 2 months

Secondary Outcome

  • Profile of HSRs (hypersensitivity reactions) in the three age groups
    date_rangeTime Frame:
    Analysis will be done in 2 months
  • General reported ADR (adverse drug reactions) profile in the three age groups
    date_rangeTime Frame:
    Analysis will be done in 2 months

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
N/A