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

NCT01475097 | Completed Phase 4 Results DMC

• 1 other identifier: GE-012-098
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Safety

Keywords

AE - Adverse event; Arteriography; IA - Intra-arterial; IOCM - Iso-Osmolar Contrast Medium; LOCM - Low-Osmolar Contrast Medium; Patient Comfort; Body Image Disturbance; Patient

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography.

  Within 10 minutes post contrast administration.

Study Arms (2)

Active Arm

ACTIVE COMPARATOR

Drug: Iodixanol

Comparator Arm

ACTIVE COMPARATOR

Drug: Iopamidol

Interventions

Iodixanol DRUG

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

Also known as: Visipaque

Active Arm

Iopamidol DRUG

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

Also known as: Isovue

Comparator Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is over 18 years old.
• Subjects are referred to undergo a peripheral arteriography as part of their routine clinical care.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GE Healthcare: lead
• i3 Statprobe: collaborator

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Interventions

iodixanol; Iopamidol

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Debra Mansfield
• Organization: GE Healthcare

dabra.mansfield@ge.com

609-514-6329

Study Officials

• Lauren Lim, PharmD

  GE Healthcare

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 21, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: June 11, 2014
• Results First Posted: April 15, 2014

Record last verified: 2014-06

Locations

US (1)