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Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT

This study has been completed.
Sponsor:
Collaborator:
GE Healthcare
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00478556
First received: May 24, 2007
Last updated: May 19, 2010
Last verified: May 2010
History of Changes
  Purpose

Patients who are scheduled by their health care provider for routine computed tomography (CT) scan will be asked to participate in this study. The primary purpose is to determine if there is a difference in patient preference for Omnipaque versus Gastroview as oral contrast for abdominal pelvic CT. A secondary objective is to evaluate if there is significant difference in bowel opacification for the two agents.


Condition Intervention Phase
Healthy
 Drug: Omnipaque
Drug: Gastroview
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT

Resource links provided by NLM:

MedlinePlus related topics: CT Scans
U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Preferred Contrast Agent [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    The primary outcome variable is the taste test when subjects will be asked which preparation they prefer. Possible answers include Onmipaque, Gastroview or neither.


Secondary Outcome Measures:
  • Bowel Opacification Score [ Time Frame: Collected day of study ] [ Designated as safety issue: No ]
    The bowel opacification score was calculated by adding values for stomach, duodenum, jejunum and ileum for each patient. They were averaged across two doctors who read the studies. Scores can range from 0 (no opacification) to 3 (excellent) for each segment and from 0 to 12 for bowel opacification score.


Enrollment: 300
Study Start Date: August 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Gastroview
 Drug: Gastroview
Oral CT contrast
Other Name: diatrizoate meglumine and diatrizoate sodium solution USP
Experimental: 2
Omnipaque
 Drug: Omnipaque
Oral CT contrast
Other Name: Iohexol

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients at least 19 years of age scheduled for outpatient contrast enhanced abdominal pelvic CT at The Kirklin Clinic in Birmingham Alabama as part of clinical care with the patient's provider will be screened for eligibility.

Exclusion Criteria:

  • Not competent to give consent.
  • Pregnant.
  • Known allergy to either of the contrast agents.
  • Loss of sense of taste or smell.
  • Contraindication to oral administration such as aspiration risk.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478556

Locations
United States, Alabama
The Kirklin Clinic
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
GE Healthcare
Investigators
Principal Investigator: Michelle McNamara, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Michelle McNamara, MD, UAB Hospital
ClinicalTrials.gov Identifier: NCT00478556     History of Changes
Other Study ID Numbers: F070208011, Omnipaque vs Gastroview Oral
Study First Received: May 24, 2007
Results First Received: February 9, 2010
Last Updated: May 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
CT scan
oral contrast

ClinicalTrials.gov processed this record on May 22, 2013