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

This study has been completed.
Sponsor:
Collaborator:
i3 Statprobe
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01475097
First received: November 3, 2011
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Drug Safety
Drug: Iodixanol
Drug: Iopamidol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography [ Time Frame: Within 10 minutes post contrast administration. ] [ Designated as safety issue: Yes ]
    The number of subjects experiencing overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.


Secondary Outcome Measures:
  • Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography. [ Time Frame: Within 10 minutes post contrast administration. ] [ Designated as safety issue: No ]
    Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration.


Enrollment: 255
Study Start Date: October 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01475097     History of Changes
Other Study ID Numbers: GE-012-098
Study First Received: November 3, 2011
Results First Received: March 11, 2014
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Iodixanol
Iopamidol
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014