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Iodixanol Versus Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic Imaging of Abdomen/Pelvis

This study has been completed.
Sponsor:
Collaborator:
i3 Statprobe
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01376089
First received: June 16, 2011
Last updated: April 12, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to evaluate and compare overall patient comfort profile between the 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 Contrast-Enhanced Computed Tomographic (CECT) imaging of the abdomen/pelvis.


Condition Intervention Phase
Patient Comfort and 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 Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Comparison of Patient comfort and safety using a grading scale during the use of Iodixanol 320 mg I/mL and Iopamidol 370 mg I/mL [ Time Frame: Time zero equals the date of contrast imaging and for up to 10 minutes for safety monitoring post contrast administration. ] [ Designated as safety issue: Yes ]
    Comparison of Patient Comfort and Safety using a grading scale of zero to 10, zero being no pain and 10 being most severe with the use of the Iodixanol 320 mg I/mL and Iopamidol 370 mg I/mL in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/pelvis.


Secondary Outcome Measures:
  • To measure the overall image quality based on the presence or absence of patient motion artifacts. [ Time Frame: Time zero equals the date of contrast imaging and for up to 10 minutes for safety monitoring post contrast administration. ] [ Designated as safety issue: Yes ]
    To measure and compare the overall image quality based on the impact of patient discomfort and movement during an imaging procedure. The overall image quality will be graded on a 3-point scale based on the presence or absence of motion artifacts.


Enrollment: 304
Study Start Date: May 2011
Study Completion Date: February 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1-Iodixanol Drug: Iodixanol
Iodixanol 320 mg I/mL as a single iv. administration.
Other Name: Visipaque
Active Comparator: Arm 2-Iopamidol Drug: Iopamidol
Comparator agent iopamidol (Isovue) 370 mg I/mL as a single iv. 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 CECT imaging of the abdomen/pelvis 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.
  • 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: NCT01376089

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: NCT01376089     History of Changes
Other Study ID Numbers: GE-012-097
Study First Received: June 16, 2011
Last Updated: April 12, 2012
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:
Safety

ClinicalTrials.gov processed this record on June 18, 2013