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Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00478556
First Posted: May 25, 2007
Last Update Posted: April 18, 2017
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.
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Michelle McNamara, MD, University of Alabama at Birmingham
  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: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Official Title: Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT

Resource links provided by NLM:


Further study details as provided by Michelle McNamara, MD, University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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:
  • 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.


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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


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

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 Submitted: May 24, 2007
First Posted: May 25, 2007
Results First Submitted: February 9, 2010
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