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: November 5, 2013
Last verified: November 2013
  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:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.

  • 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. ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration.


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
Results First Received: May 30, 2013
Last Updated: November 5, 2013
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 April 17, 2014