NCT01376089

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
304

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

December 19, 2013

Completed
Last Updated

December 19, 2013

Status Verified

November 1, 2013

Enrollment Period

5 months

First QC Date

June 16, 2011

Results QC Date

May 30, 2013

Last Update Submit

November 5, 2013

Conditions

Patient Comfort and Safety

Keywords

Safety

Outcome Measures

Primary Outcomes (2)

  • Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.

    Number of subjects experiencing any moderate (score of 4 - 7) to severe (score 8 - 10) discomfort for cold or heat or pain between Iodixanol and Iopamidol.

    Within 10 minutes post contrast administration

  • Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.

    Number of subjects experiencing moderate (score of 4 -7) to severe (score of 8 - 10) discomfort for cold, heat or pain between Iodixanol and Iopamidol.

    Within 10 minutes post contrast administration.

Secondary Outcomes (1)

  • Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.

    Ten minutes post contrast administration.

Study Arms (2)

Arm 1-Iodixanol

OTHER
Drug: Iodixanol

Arm 2-Iopamidol

ACTIVE COMPARATOR
Drug: Iopamidol

Interventions

IodixanolDRUG

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

Also known as: Visipaque
Arm 1-Iodixanol
IopamidolDRUG

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

Also known as: Isovue
Arm 2-Iopamidol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GE Healthcare

Princeton, New Jersey, 08540, United States

Location

MeSH Terms

Interventions

iodixanolIopamidol

Intervention Hierarchy (Ancestors)

Triiodobenzoic AcidsIodobenzoatesBenzoatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Lauren Lim, PharmD
Organization
GE Healthcare
lauren.lim@ge.com
1-626-356-1937

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

June 16, 2011

First Posted

June 20, 2011

Study Start

May 1, 2011

Primary Completion

October 1, 2011

Study Completion

February 1, 2012

Last Updated

December 19, 2013

Results First Posted

December 19, 2013

Record last verified: 2013-11

Locations

US(1)