Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

i3 Statprobe

Information provided by (Responsible Party):

GE Healthcare

ClinicalTrials.gov Identifier:

NCT01475097

First received: November 3, 2011

Last updated: February 14, 2013

Last verified: February 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

November 3, 2011

Last Updated Date

February 14, 2013

Start Date ^ICMJE

October 2011

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Measure Patient Comfort and Safety between Iodixanol 320 mg I/mL and Iopamidol 370 mg I/mL in Patients Undergoing angiography [ Time Frame: The safety and discomfort measurement will start after the initial contrast media injection, within 10 minutes of injection, and then the patient will be followed and evaluated for 24 hours post injection. ] [ Designated as safety issue: Yes ]

Measurement of Patient Comfort and Safety between Iodixanol 320 mg I/mL and Iopamidol 370 mg I/mL in Patients Undergoing angiography of the peripheral arteries as indicated by the intensity of pain and sensations of coldness and/or heat. These will be rated verbally by the patient on a scale of 0 to 10.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01475097 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluation of patient discomfort on overall image quality [ Time Frame: At the time the x-ray image is captured, the image will immediately be assessed by the reader using a three-point qualitative scale based solely on the presence or absence of motion artifact. ] [ Designated as safety issue: No ]

Evaluation of patient discomfort on image procedure and overall image quality using a three-point qualitative scale based solely on the presence or absence of motion artifacts.

Original Secondary Outcome Measures ^ICMJE

Evaluation of patient discomfort and overall image quality [ Time Frame: At the time the x-ray image is captured, the image will immediately be assessed by the reader using a three-point qualitative scale based solely on the presence or absence of motion artifact. ] [ Designated as safety issue: No ]

Evaluation of patient discomfort on image procedure and overall image quality using a three-point qualitative scale based solely on the presence or absence of motion artifacts.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography

Official Title ^ICMJE

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 Peripheral Arteriography

Brief Summary

The purpose of this study is to evaluate and compare overall patient comfort profile between an 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 arteriography of peripheral arteries.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Condition ^ICMJE

Drug Safety

Intervention ^ICMJE

Drug: Iodixanol
Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.

Other Name: Visipaque
Drug: Iopamidol
Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.

Other Name: Isovue

Study Arm (s)

Active Comparator: Active Arm
Intervention: Drug: Iodixanol
Active Comparator: Comparator Arm
Intervention: Drug: Iopamidol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

250

Estimated Completion Date

March 2013

Estimated Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

The subject is over 18 years old.
Subjects are referred to undergo a peripheral arteriography 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 or lactating.
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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01475097

Other Study ID Numbers ^ICMJE

GE-012-098

Has Data Monitoring Committee

Yes

Responsible Party

GE Healthcare

Study Sponsor ^ICMJE

GE Healthcare

Collaborators ^ICMJE

i3 Statprobe

Investigators ^ICMJE

Study Director:

Lauren Lim, PharmD

GE Healthcare

Information Provided By

GE Healthcare

Verification Date

February 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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