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: March 11, 2014
Last verified: March 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
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: March 11, 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

ClinicalTrials.gov processed this record on April 14, 2014