- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00876083
PMS Study Ultravist-IMAGE, IoproMide (UltrAvist) to Gain Further Information on Tolerability and Safety in X-ray Examination (IMAGE)
February 25, 2011 updated by: Bayer
Post-marketing Surveillance Study Ultravist®-IMAGE IoproMide (UltrAvist®) to Gain Further Information on Tolerability and Safety in X-ray Examination
The purpose of this study is to obtain data on the safety and efficacy of Ultravist application in usual daily use.The radiologist will administer the contrast medium to the patient as he/she would have done without the study.
No other examinations will be performed than would have been done routinely.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
44920
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Many Locations, Bosnia and Herzegovina
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Many Locations, China
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Many Locations, Germany
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Many Locations, Hungary
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Many Locations, Indonesia
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Many Locations, Iran, Islamic Republic of
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Many Locations, Italy
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Many Locations, Korea, Republic of
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Many Locations, Malaysia
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Many Locations, Moldova, Republic of
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Many Locations, Pakistan
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Many Locations, Philippines
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Many Locations, Poland
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Many Locations, Romania
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Many Locations, Russian Federation
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Many Locations, Saudi Arabia
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Many Locations, Singapore
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Many Locations, Taiwan
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Many Locations, Thailand
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Many Locations, Ukraine
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Many Locations, Vietnam
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study population will consist of female and male patients who require an X-ray examination with contrast enhancement.
Physicians should consult the full prescribing information for Ultravist before enrolling patients and familiarize themselves with the safety information in the product package label.
Description
Inclusion Criteria:
- Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.
Exclusion Criteria:
- No exclusion criteria besides the contraindications for the use of Ultravist as mentioned in the product information.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Group 1
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Patients with indication for an X-ray examination and for whom the radiologist has decided to use the contrast medium Ultravist.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Occurrence of adverse events
Time Frame: During and after Ultravist application on the day of examination
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During and after Ultravist application on the day of examination
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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General contrast quality in the region of interest as assessed by physicians
Time Frame: On the day of examination
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On the day of examination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
April 3, 2009
First Submitted That Met QC Criteria
April 3, 2009
First Posted (Estimate)
April 6, 2009
Study Record Updates
Last Update Posted (Estimate)
February 28, 2011
Last Update Submitted That Met QC Criteria
February 25, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 14692
- 13859
- 13421
- 14338
- UV0701
- 13422
- 14480
- 13276
- 14336
- 14181
- 13602
- 14243
- 13275
- 14180
- 14376
- 14337
- 14245
- 13212
- 14526
- 14527
- 14528
- 14586
- 14661
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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