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Iodixanol Versus Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic Imaging of Abdomen/Pelvis | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

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

NCT01376089•GE Healthcare

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

GE Healthcare

Princeton, New Jersey, United States

Key Dates

Start Date

May 1, 2011

Primary Completion Date

October 1, 2011

Completion Date

February 1, 2012

Last Updated

December 19, 2013

Enrollment

304

ACTUAL participants

Conditions

Patient Comfort and Safety

Interventions

Iodixanol

DRUG

Iopamidol

DRUG