Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT

This study is currently recruiting participants.

Verified by University of Alabama at Birmingham, April 2009

First Received: May 24, 2007 Last Updated: April 21, 2009 History of Changes

Sponsors and Collaborators:	University of Alabama at Birmingham GE Healthcare
Information provided by:	University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00478556

Purpose

Patients who are scheduled by their health care provider for routine 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 IV

Drug Information available for: Amidotrizoic Acid Iohexol Diatrizoate Diatrizoate meglumine Diatrizoate Sodium Urovision

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment
Official Title:	Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT

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

Primary Outcome Measures:

The primary outcome variable is the taste test when subjects will be asked which preparation they prefer. Possible answers include Onmipaque, Gastroview or neither. [ Time Frame: Day of CT scan ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Gastroview	Drug: Gastroview Oral CT contrast
2: Experimental Omnipaque	Drug: Omnipaque Oral CT contrast

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

Contacts

Contact: Lisa A. Nelson, RN, BSN	205-934-4015	lnelson@uabmc.edu
Contact: Jennifer C Boyd	205-934-4080	jboyd@uabmc.edu

Locations

United States, Alabama
The Kirklin Clinic	Recruiting
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:	UAB Hospital ( Michelle McNamara, MD )
Study ID Numbers:	F070208011, Omnipaque vs Gastroview Oral
Study First Received:	May 24, 2007
Last Updated:	April 21, 2009
ClinicalTrials.gov Identifier:	NCT00478556 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

CT scan
oral contrast

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009