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

Drug Safety Clinical Trial

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 Peripheral Arteriography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475097
• Other study ID #: GE-012-098
• 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., Glucophage®) 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

• Drug Safety

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