Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT

This study has been completed.
Sponsor:
Collaborator:
GE Healthcare
Information provided by:
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00478556
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
No text entered.

Reporting Groups
  Description
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
  Description
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 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   111   96   207 
>=65 years   40   53   93 
Age 
[Units: Years]
Mean (Standard Deviation)
 56  (15)   57  (15)   57  (15) 
Gender 
[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
e-mail: lnelson@uabmc.edu



Responsible Party: Michelle McNamara, MD, UAB Hospital
ClinicalTrials.gov 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