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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01475097
Other study ID # GE-012-098
Secondary ID
Status Completed
Phase Phase 4
First received November 3, 2011
Last updated June 3, 2014
Start date October 2011
Est. completion date February 2013

Study information

Verified date June 2014
Source GE Healthcare
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardGermany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 255
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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., GlucophageĀ®) but is not willing or unable to discontinue at the time of the study procedure.

- The subject manifests thyrotoxicosis or is on dialysis.

Study Design

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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States GE Healthcare Princeton New Jersey

Sponsors (2)

Lead Sponsor Collaborator
GE Healthcare i3 Statprobe

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography The number of subjects experiencing overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging. Within 10 minutes post contrast administration. Yes
Secondary Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography. Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration. Within 10 minutes post contrast administration. No
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