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

November 5, 2013 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 Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

304

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

  • United States
    • 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 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.

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
OTHER: Arm 1-Iodixanol
Drug: Iodixanol
Iodixanol 320 mg I/mL as a single iv. administration.
Other Names:
  • Visipaque
ACTIVE_COMPARATOR: Arm 2-Iopamidol
Drug: Iopamidol
Comparator agent iopamidol (Isovue) 370 mg I/mL as a single iv. administration.
Other Names:
  • Isovue

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
Time Frame: Within 10 minutes post contrast administration
Number of subjects experiencing any moderate (score of 4 - 7) to severe (score 8 - 10) discomfort for cold or heat or pain between Iodixanol and Iopamidol.
Within 10 minutes post contrast administration
Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
Time Frame: Within 10 minutes post contrast administration.
Number of subjects experiencing moderate (score of 4 -7) to severe (score of 8 - 10) discomfort for cold, heat or pain between Iodixanol and Iopamidol.
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 Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
Time Frame: Ten minutes post contrast administration.
Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration.
Ten minutes post contrast administration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GE Healthcare

Collaborators

i3 Statprobe

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

May 1, 2011

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

February 1, 2012

Study Registration Dates

First Submitted

June 16, 2011

First Submitted That Met QC Criteria

June 17, 2011

First Posted (ESTIMATE)

June 20, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

December 19, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GE-012-097

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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