- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01475097
Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography
June 3, 2014 updated by: GE Healthcare
A Phase 4 Randomized, Double-blind Study Comparing Patient Comfort and Safety Between Iodixanol 320 mg I/mL and Iopamidol 370 mg I/mL in Patients Undergoing Peripheral Arteriography
The purpose of this study is to evaluate and compare overall patient comfort profile between an Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing arteriography of peripheral arteries.
Study Overview
Study Type
Interventional
Enrollment (Actual)
255
Phase
- Phase 4
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
-
-
New Jersey
-
Princeton, New Jersey, United States, 08540
- GE Healthcare
-
-
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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The subject is over 18 years old.
- Subjects are referred to undergo a peripheral arteriography as part of their routine clinical care.
Exclusion Criteria:
- The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM.
- The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within the 24 hour follow-up period.
- The subject is pregnant or lactating.
- The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to discontinue at the time of the study procedure.
- The subject manifests thyrotoxicosis or is on dialysis.
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
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Active Arm
|
Iodixanol 320 mg I/mL given by intra-arterial administration.
Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
Other Names:
|
ACTIVE_COMPARATOR: Comparator Arm
|
Iodixanol 320 mg I/mL given by intra-arterial administration.
Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography
Time Frame: Within 10 minutes post contrast administration.
|
The number of subjects experiencing overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.
|
Within 10 minutes post contrast administration.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography.
Time Frame: Within 10 minutes post contrast administration.
|
Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration.
|
Within 10 minutes post contrast administration.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Lauren Lim, PharmD, GE Healthcare
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
October 1, 2011
Primary Completion (ACTUAL)
February 1, 2013
Study Completion (ACTUAL)
February 1, 2013
Study Registration Dates
First Submitted
November 3, 2011
First Submitted That Met QC Criteria
November 16, 2011
First Posted (ESTIMATE)
November 21, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
June 11, 2014
Last Update Submitted That Met QC Criteria
June 3, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GE-012-098
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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