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Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00478556
Recruitment Status : Completed
First Posted : May 25, 2007
Results First Posted : June 11, 2010
Last Update Posted : April 18, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: Omnipaque Drug: Gastroview Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT
Study Start Date : August 2007
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Iohexol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Drug: Gastroview
Oral CT contrast
Other Name: diatrizoate meglumine and diatrizoate sodium solution USP
Experimental: 2
Drug: Omnipaque
Oral CT contrast
Other Name: Iohexol

Outcome Measures

Primary Outcome Measures :
  1. Preferred Contrast Agent [ Time Frame: 1 Day ]
    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 :
  1. Bowel Opacification Score [ Time Frame: Collected day of study ]
    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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478556

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

Responsible Party: Michelle McNamara, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT00478556     History of Changes
Other Study ID Numbers: F070208011
Omnipaque vs Gastroview Oral ( Other Identifier: Department Name )
First Posted: May 25, 2007    Key Record Dates
Results First Posted: June 11, 2010
Last Update Posted: April 18, 2017
Last Verified: March 2017

Keywords provided by Michelle McNamara, MD, University of Alabama at Birmingham:
CT scan
oral contrast