Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00478556
Recruitment Status : Completed
First Posted : May 25, 2007
Results First Posted : June 11, 2010
Last Update Posted : April 18, 2017
GE Healthcare
Information provided by (Responsible Party):
Michelle McNamara, MD, University of Alabama at Birmingham

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

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

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

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

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

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 )
First Submitted: May 24, 2007
First Posted: May 25, 2007
Results First Submitted: February 9, 2010
Results First Posted: June 11, 2010
Last Update Posted: April 18, 2017