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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.
ClinicalTrials.gov Identifier: NCT00478556
Recruitment Status : Completed
First Posted : May 25, 2007
Results First Posted : June 11, 2010
Last Update Posted : April 18, 2017
Sponsor:
Collaborator:
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
Enrollment 300
Recruitment Details 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  
Arm/Group Title Gastroview Group Omnipaque Group
Hide Arm/Group Description Patients will be given oral Gastroview (contrast) prior to Computerized Tomography (CT). Patients ill be given oral Omnipaque (contrast) prior to Computerized Tomography (CT).
Period Title: Overall Study
Started 151 149
Completed 151 149
Not Completed 0 0
Arm/Group Title Gastroview Omnipaque Total
Hide Arm/Group Description Oral Gastroview prior to CT Oral Omnipaque prior to CT Total of all reporting groups
Overall Number of Baseline Participants 151 149 300
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 149 participants 300 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%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 151 participants 149 participants 300 participants
56  (15) 57  (15) 57  (15)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 151 participants 149 participants 300 participants
Female
60
  39.7%
56
  37.6%
116
  38.7%
Male
91
  60.3%
93
  62.4%
184
  61.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 151 participants 149 participants 300 participants
151 149 300
1.Primary Outcome
Title Preferred Contrast Agent
Hide Description The primary outcome variable is the taste test when subjects will be asked which preparation they prefer. Possible answers include Onmipaque, Gastroview or neither.
Time Frame 1 Day
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was per protocol
Arm/Group Title Gastroview Omnipaque
Hide Arm/Group Description:
Oral Gastroview prior to CT
Oral Omnipaque prior to CT
Overall Number of Participants Analyzed 151 149
Measure Type: Number
Unit of Measure: participants
Prefer Gastroview 25 29
Prefer Omnipaque 117 116
No Preference 9 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gastroview, Omnipaque
Comments All individuals tasted both preparations and indicated preference. A binomial test of proportion was done to see if these values differed from 50%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Binomial test of proportion
Comments tested if values were different from 50%
Method of Estimation Estimation Parameter difference in proportions
Estimated Value 62
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Bowel Opacification Score
Hide Description 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.
Time Frame Collected day of study
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol - all patients had usable data
Arm/Group Title Gastroview Omnipaque
Hide Arm/Group Description:
Oral Gastroview prior to CT
Oral Omnipaque prior to CT
Overall Number of Participants Analyzed 151 149
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.57  (1.96) 8.85  (1.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gastroview, Omnipaque
Comments Wilcoxon Rank Sum test was used to assess differences in bowel opacification score between the two groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.270
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gastroview Omnipaque
Hide Arm/Group Description Oral Gastroview prior to CT Oral Omnipaque prior to CT
All-Cause Mortality
Gastroview Omnipaque
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gastroview Omnipaque
Affected / at Risk (%) Affected / at Risk (%)
Total   0/151 (0.00%)   0/149 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gastroview Omnipaque
Affected / at Risk (%) Affected / at Risk (%)
Total   0/151 (0.00%)   0/149 (0.00%) 
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
ClinicalTrials.gov 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