Contrast MediumUVIANCT03622801
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 of Contrast Medium, run by Bayer at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast Medium
- What is being tested?
- Iopromide (Ultravist, BAY86-4877)
- Type of treatment
- Injection or infusion
- How many people
- 133,331 participants
- Where
- 1 siteGermany
- Study dates
- 12 Oct 2018to 14 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk of Anaphylactoid Reactions of Iopromide After Intra-arterial Administration
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.
- Conditions
- Contrast Medium
- Being tested
- Iopromide (Ultravist, BAY86-4877)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iopromide (Ultravist, BAY86-4877)Drug
Patients who have received Iopromide (iodine concentrations of 300 mg/mL or 370 mg/mL) either intra-venously or intra-arterially.
| Study group | Role | What they receive |
|---|---|---|
| Intra-arterial administration | Patients with intra-arterial administration of Iopromide Receives: Drug: Iopromide (Ultravist, BAY86-4877) | |
| Intravenous administration | Patients with intravenous administration of Iopromide Receives: Drug: Iopromide (Ultravist, BAY86-4877) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with anaphylactoid reactions of Iopromide after administration
Measured: Retrospective analysis from 31 Aug 2010 to 30 Sep 2011
Secondary outcomes (2)
Number of patients with anaphylactoid reactions after intra-arterial administration of Iopromide
Measured: Retrospective analysis from 31 Aug 2010 to 30 Sep 2011
Number of patients with anaphylactoid reactions after intra-venous administration of Iopromide
Measured: Retrospective analysis from 31 Aug 2010 to 30 Sep 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start12 Oct 2018
- Primary completion14 Feb 2019
- Study completion14 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast MediumStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 133,331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622801
- Sponsor's protocol ID
- 19677
- Acronym
- UVIA
- Status last verified
- Feb 2020
- First submitted
- 6 Aug 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Anaphylactoid Reactions of Iopromide After Intra-arterial Administration
- ClinicalTrials.gov ID
- NCT03622801
- Acronym / sponsor ID
- UVIA / 19677
- Conditions
- Contrast Medium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133,331 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 14 Feb 2019 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-arterial administration | – | Drug: Iopromide (Ultravist, BAY86-4877)Patients with intra-arterial administration of Iopromide |
| Intravenous administration | – | Drug: Iopromide (Ultravist, BAY86-4877)Patients with intravenous administration of Iopromide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iopromide (Ultravist, BAY86-4877)Patients who have received Iopromide (iodine concentrations of 300 mg/mL or 370 mg/mL) either intra-venously or intra-arterially. | Drug | Intra-arterial administration, Intravenous administration |
Primary outcome
Number of patients with anaphylactoid reactions of Iopromide after administration
Time frame: Retrospective analysis from 31 Aug 2010 to 30 Sep 2011
2 secondary outcomes
Number of patients with anaphylactoid reactions after intra-arterial administration of Iopromide
Time frame: Retrospective analysis from 31 Aug 2010 to 30 Sep 2011
Number of patients with anaphylactoid reactions after intra-venous administration of Iopromide
Time frame: Retrospective analysis from 31 Aug 2010 to 30 Sep 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Contrast Medium, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with anaphylactoid reactions of Iopromide after administration (time frame: Retrospective analysis from 31 Aug 2010 to 30 Sep 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.