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Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT

This study has been completed.
GE Healthcare
Information provided by (Responsible Party):
Michelle McNamara, MD, University of Alabama at Birmingham Identifier:
First received: May 24, 2007
Last updated: March 22, 2017
Last verified: March 2017
Results First Received: February 9, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, 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
Patients will be randomized to receive either a standardized dilution of Gastroview or Omnipaque orally. The two agents will be prepared to have nearly equivalent iodine concentration.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Gastroview Group Patients will be given oral Gastroview (contrast) prior to Computerized Tomography (CT).
Omnipaque Group Patients ill be given oral Omnipaque (contrast) prior to Computerized Tomography (CT).

Participant Flow:   Overall Study
    Gastroview Group   Omnipaque Group
STARTED   151   149 
COMPLETED   151   149 

  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.
No text entered.

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 
Overall Participants Analyzed 
[Units: Participants]
 151   149   300 
[Units: Participants]
Count of Participants
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      111  73.5%      96  64.4%      207  69.0% 
>=65 years      40  26.5%      53  35.6%      93  31.0% 
[Units: Years]
Mean (Standard Deviation)
 56  (15)   57  (15)   57  (15) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      60  39.7%      56  37.6%      116  38.7% 
Male      91  60.3%      93  62.4%      184  61.3% 
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, University of Alabama at Birmingham 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: March 22, 2017