Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT

This study has been completed.
GE Healthcare
Information provided by:
University of Alabama at Birmingham Identifier:
First received: May 24, 2007
Last updated: May 19, 2010
Last verified: May 2010
Results First Received: February 9, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Diagnostic
Condition: Healthy
Interventions: Drug: Omnipaque
Drug: Gastroview

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Gastroview Oral Gastroview prior to CT
Omnipaque Oral Omnipaque prior to CT

Participant Flow:   Overall Study
    Gastroview     Omnipaque  
STARTED     151     149  
COMPLETED     151     149  
NOT COMPLETED     0     0  

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Gastroview Oral Gastroview prior to CT
Omnipaque Oral Omnipaque prior to CT
Total Total of all reporting groups

Baseline Measures
    Gastroview     Omnipaque     Total  
Number of Participants  
[units: participants]
  151     149     300  
[units: participants]
<=18 years     0     0     0  
Between 18 and 65 years     111     96     207  
>=65 years     40     53     93  
[units: years]
Mean (Standard Deviation)
  56  (15)     57  (15)     57  (15)  
[units: participants]
Female     60     56     116  
Male     91     93     184  
Region of Enrollment  
[units: participants]
United States     151     149     300  

  Outcome Measures
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1.  Primary:   Preferred Contrast Agent   [ Time Frame: 1 Day ]

2.  Secondary:   Bowel Opacification Score   [ Time Frame: Collected day of study ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was completed.

  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Lisa Nelson
Organization: UAB Hospital Radiology
phone: 205-934-4015

Responsible Party: Michelle McNamara, MD, UAB Hospital Identifier: NCT00478556     History of Changes
Other Study ID Numbers: F070208011
Omnipaque vs Gastroview Oral ( Other Identifier: Department Name )
Study First Received: May 24, 2007
Results First Received: February 9, 2010
Last Updated: May 19, 2010
Health Authority: United States: Institutional Review Board