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

NCT ID: NCT01376089

Last Updated: 2013-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Patient Comfort and Safety

Keywords

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Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1-Iodixanol

Group Type OTHER

Iodixanol

Intervention Type DRUG

Iodixanol 320 mg I/mL as a single iv. administration.

Arm 2-Iopamidol

Group Type ACTIVE_COMPARATOR

Iopamidol

Intervention Type DRUG

Comparator agent iopamidol (Isovue) 370 mg I/mL as a single iv. administration.

Interventions

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Iodixanol

Iodixanol 320 mg I/mL as a single iv. administration.

Intervention Type DRUG

Iopamidol

Comparator agent iopamidol (Isovue) 370 mg I/mL as a single iv. administration.

Intervention Type DRUG

Other Intervention Names

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Visipaque Isovue

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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i3 Statprobe

INDUSTRY

Sponsor Role collaborator

GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lauren Lim, PharmD

Role: STUDY_DIRECTOR

GE Healthcare

Locations

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GE Healthcare

Princeton, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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GE-012-097

Identifier Type: -

Identifier Source: org_study_id