Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT
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|ClinicalTrials.gov Identifier: NCT00478556|
Recruitment Status : Completed
First Posted : May 25, 2007
Results First Posted : June 11, 2010
Last Update Posted : April 18, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Omnipaque Drug: Gastroview||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||March 2009|
|Actual Study Completion Date :||March 2009|
Active Comparator: 1
Oral CT contrast
Other Name: diatrizoate meglumine and diatrizoate sodium solution USP
Oral CT contrast
Other Name: Iohexol
- 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.
- 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.
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|Ages Eligible for Study:||19 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- Not competent to give consent.
- Known allergy to either of the contrast agents.
- Loss of sense of taste or smell.
- Contraindication to oral administration such as aspiration risk.
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|
|Principal Investigator:||Michelle McNamara, MD||University of Alabama at Birmingham|
|Responsible Party:||Michelle McNamara, MD, Principal Investigator, University of Alabama at Birmingham|
|Other Study ID Numbers:||
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|