Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT

• Sponsor: University of Alabama at Birmingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT00478556
• Collaborator: GE Healthcare (Industry)
• Enrollment: 300
• Location: 1
• Arms: 2
• Duration (Months): 19
• Patients Per Site Per Month: 15.8

Study Details

Study Description

Brief Summary

Patients who are scheduled by their health care provider for routine computed tomography (CT) scan will be asked to participate in this study. The primary purpose is to determine if there is a difference in patient preference for Omnipaque versus Gastroview as oral contrast for abdominal pelvic CT. A secondary objective is to evaluate if there is significant difference in bowel opacification for the two agents.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Omnipaque; Drug: Gastroview	Phase 4

Detailed Description

Participants must be scheduled for a CT scan prior to enrollment in this study. Informed consent will be obtained from patients acceptable to be included in the study. It will be noted if there is a history of gastrointestinal surgery and if the patient is nauseated before the contrast is administered.

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. No flavoring agent (ie Crystal Light) will be added. The plan is to mix the agents per manufacturer recommendation as follows:

Omnipaque 350 26cc in 974 cc of water (9.0g iodine) Gastroview 25cc in 1000cc of water (9.17g iodine)

The time the patients start and stop consuming the contrast as well as the volume taken and time from first drink to start of the scan will be recorded by a blinded investigator. Patients will be asked to drink 900cc. Technical staff will report any side effects or complications observed.

After completion of the CT scan, patients will fill in a survey rating the taste of the agent on a 5 point scale, and will be asked to report any side effects. Planned rating scale is as follows:

• 2=Dislike very much

• 1=Dislike moderately 0=Neither like nor dislike

• 1=Like moderately

• 2=Like very much

A taste test between the two agents will then be administered by a blinded investigator. Patients will be given 30 cc of each agent. The order in which the agents are administered will be randomized. Patients will be asked to rate preference, if any, for either agent on a 3 point scale. Potential bias related to which agent was administered for the CT will analyzed from the data.

Planned rating scale is as follows:

• 1- A is better 0 -no difference

• 1- B is better

Patients will be contacted by telephone the day after the CT to assess for any delayed side effects such as diarrhea, constipation, and abdominal cramping experienced in the 24 hours following.

Bowel opacification will be rated by 2 body imagers blinded to the agent the patient received. Degree of opacification of the stomach, duodenum, jejunum, and ileum will be rated on a 4 point scale. If contrast has reached the colon, ascending, transverse, descending and sigmoid will be similarly evaluated. Four point rating scale is as follows:

0= absent opacification

1. minimal (<25% of analyzed segments opacified)

2. good (>25 % and < 75% of analyzed segments opacified)

3. excellent (> 75% of analyzed segments opacified)

Description of tests/procedures to be performed. Patients will undergo contrast enhanced abdominal pelvis CT as ordered by the referring clinician. Patients will be randomized to either dilute Omnipaque or dilute Gastroview for oral contrast. Both agents will be in a concentration of 9 mg of iodine/ml, and a volume of 900 cc.

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Diagnostic
• Official Title: Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Gastroview	Drug: Gastroview; Oral CT contrast; Other Names: diatrizoate meglumine and diatrizoate sodium solution USP
Experimental: 2 Omnipaque	Drug: Omnipaque; Oral CT contrast; Other Names: Iohexol

Outcome Measures

Primary Outcome Measures

1. Preferred Contrast Agent [1 Day]

   The primary outcome variable is the taste test when subjects will be asked which preparation they prefer. Possible answers include Onmipaque, Gastroview or neither.

Secondary Outcome Measures

1. Bowel Opacification Score [Collected day of study]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients at least 19 years of age scheduled for outpatient contrast enhanced abdominal pelvic CT at The Kirklin Clinic in Birmingham Alabama as part of clinical care with the patient's provider will be screened for eligibility.

Exclusion Criteria:

• Not competent to give consent.

• Pregnant.

• Known allergy to either of the contrast agents.

• Loss of sense of taste or smell.

• Contraindication to oral administration such as aspiration risk.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Kirklin Clinic	Birmingham	Alabama	United States	35249

Sponsors and Collaborators

• University of Alabama at Birmingham
• GE Healthcare

Investigators

• Principal Investigator: Michelle McNamara, MD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michelle McNamara, MD, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT00478556
• Other Study ID Numbers: F070208011; Omnipaque vs Gastroview Oral
• First Posted: May 25, 2007
• Last Update Posted: Apr 18, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by Michelle McNamara, MD, Principal Investigator, University of Alabama at Birmingham: CT scan; oral contrast

Study Results

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.

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 Participants	151	149	300
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	111 73.5%	96 64.4%	207 69%
>=65 years	40 26.5%	53 35.6%	93 31%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56 (15)	57 (15)	57 (15)
Sex: Female, Male (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 (participants) [Number]
United States	151 100%	149 100%	300 100%

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
Measure Participants	151	149
Prefer Gastroview	25 16.6%	29 19.5%
Prefer Omnipaque	117 77.5%	116 77.9%
No Preference	9 6%	4 2.7%

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
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Binomial test of proportion
	Comments	tested if values were different from 50%
Method of Estimation	Estimation Parameter	difference in proportions
	Estimated Value	62
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

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
Measure Participants	151	149
Mean (Standard Deviation) [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
Statistical Test of Hypothesis	p-Value	0.270
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Gastroview		Omnipaque
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/151 (0%)		0/149 (0%)
Other (Not Including Serious) Adverse Events
	Gastroview		Omnipaque
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/151 (0%)		0/149 (0%)

Limitations/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.