Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT
2 other identifiers
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 healthy
Started Aug 2007
Typical duration for phase_4 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2007
CompletedFirst Posted
Study publicly available on registry
May 25, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
June 11, 2010
CompletedApril 18, 2017
March 1, 2017
1.6 years
May 24, 2007
February 9, 2010
March 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Preferred Contrast Agent
The primary outcome variable is the taste test when subjects will be asked which preparation they prefer. Possible answers include Onmipaque, Gastroview or neither.
1 Day
Secondary Outcomes (1)
Bowel Opacification Score
Collected day of study
Study Arms (2)
1
ACTIVE COMPARATORGastroview
2
EXPERIMENTALOmnipaque
Interventions
Oral CT contrast
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- GE Healthcarecollaborator
Study Sites (1)
The Kirklin Clinic
Birmingham, Alabama, 35249, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Study was completed.
Results Point of Contact
- Title
- Lisa Nelson
- Organization
- UAB Hospital Radiology
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle McNamara, MD
University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 24, 2007
First Posted
May 25, 2007
Study Start
August 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
April 18, 2017
Results First Posted
June 11, 2010
Record last verified: 2017-03