We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01475097
Recruitment Status : Completed
First Posted : November 21, 2011
Results First Posted : April 15, 2014
Last Update Posted : June 11, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Drug Safety Drug: Iodixanol Drug: Iopamidol Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: 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
Study Start Date : October 2011
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Active Arm Drug: Iodixanol
Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
Other Name: Visipaque
Active Comparator: Comparator Arm Drug: Iopamidol
Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
Other Name: Isovue


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475097


Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
i3 Statprobe
Investigators
Study Director: Lauren Lim, PharmD GE Healthcare
More Information

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01475097     History of Changes
Other Study ID Numbers: GE-012-098
First Posted: November 21, 2011    Key Record Dates
Results First Posted: April 15, 2014
Last Update Posted: June 11, 2014
Last Verified: June 2014

Keywords provided by GE Healthcare:
AE - Adverse event
Arteriography
IA - Intra-arterial
IOCM - Iso-Osmolar Contrast Medium
LOCM - Low-Osmolar Contrast Medium
Patient Comfort
Body Image Disturbance
Patient