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CompletedNCT03622801UVIAUpdated Feb 17, 2020

Study on the Risk of Allergy-like Reactions After Intra-arterial or Intra-venous Injection of the Marketed X-ray Contrast Medium Iopromid

An observational study in Contrast Medium, sponsored by Bayer. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-17.

Sponsored by Bayer · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
133,331
Ages
18 Years and older
Sex
All
01

Study summary

Iopromide (trade name is Ultravist) is on the market for more than 30 years and has been used more than 250 million times as X-ray contrast medium for patients. It is known that Iopromide may cause allergy-like reactions after being injected. With this study researchers want to find out, if the risk of severe allergy-like reactions is lower, when Iopromide will be injected into an artery, compared to the risk after an injection of Iopromid into a vein. To find this out data from four trials on Iopromide that are already completed will be combined and newly analyzed. The database used for this analysis will contain data from more than 150,000 patients.

02

Conditions studied

  • Contrast Medium
03

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population consists of patients who received a contrast enhanced x-ray examination with Iopromide for various clinical reasons. Iopromide was administered either intra-venously or intra-arterially.

Eligibility criteria

The study population consists of patients who received a contrast enhanced x-ray examination with Iopromide for various clinical reasons. Iopromide was administered either intra-venously or intra-arterially.

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
133,331 participants (actual)
Patient registry
No

Groups and cohorts

  • Intra-arterial administration

    Patients with intra-arterial administration of Iopromide

    Drug: Iopromide (Ultravist, BAY86-4877)

  • Intravenous administration

    Patients with intravenous administration of Iopromide

    Drug: Iopromide (Ultravist, BAY86-4877)

Interventions

  • DrugIopromide (Ultravist, BAY86-4877)

    Patients who have received Iopromide (iodine concentrations of 300 mg/mL or 370 mg/mL) either intra-venously or intra-arterially.

06

What researchers measure

Primary outcomes

  1. Number of patients with anaphylactoid reactions of Iopromide after administration

    Time frame: Retrospective analysis from 31 Aug 2010 to 30 Sep 2011

Secondary outcomes

  1. Number of patients with anaphylactoid reactions after intra-arterial administration of Iopromide

    Time frame: Retrospective analysis from 31 Aug 2010 to 30 Sep 2011

  2. Number of patients with anaphylactoid reactions after intra-venous administration of Iopromide

    Time frame: Retrospective analysis from 31 Aug 2010 to 30 Sep 2011

07

Study locations

1 site
  • Many Locations
    Multiple Locations, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03622801
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Aug 9, 2018
Start date
Oct 12, 2018
Primary completion
Feb 14, 2019
Completion
Feb 14, 2019
Last update
Feb 17, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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