Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT

• 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: University of Alabama at Birmingham
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Gastroview	Omnipaque	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Preferred Contrast Agent
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

Outcome Measure Data

Analysis Population Description

Analysis was per protocol

Arm/Group Title	Gastroview	Omnipaque
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

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
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

Outcome Measure Data

Analysis Population Description

per protocol - all patients had usable data

Arm/Group Title	Gastroview	Omnipaque
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)

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]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Gastroview	Omnipaque
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	--/--	--/--
Serious Adverse Events
	Gastroview	Omnipaque
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/151 (0.00%)	0/149 (0.00%)
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%)

Limitations and Caveats

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
• EMail: lnelson@uabmc.edu

• Responsible Party: Michelle McNamara, MD, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT00478556
• 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