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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

Tracking Information
First Submitted Date  ICMJE May 24, 2007
First Posted Date  ICMJE May 25, 2007
Results First Submitted Date  ICMJE February 9, 2010
Results First Posted Date  ICMJE June 11, 2010
Last Update Posted Date April 18, 2017
Study Start Date  ICMJE August 2007
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 19, 2010)
Preferred Contrast Agent [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2007)
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: Day of CT scan ]
Change History Complete list of historical versions of study NCT00478556 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2010)
Bowel Opacification Score [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT
Official Title  ICMJE Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Omnipaque
    Oral CT contrast
    Other Name: Iohexol
  • Drug: Gastroview
    Oral CT contrast
    Other Name: diatrizoate meglumine and diatrizoate sodium solution USP
Study Arms  ICMJE
  • Active Comparator: 1
    Gastroview
    Intervention: Drug: Gastroview
  • Experimental: 2
    Omnipaque
    Intervention: Drug: Omnipaque
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 19, 2010)
300
Original Estimated Enrollment  ICMJE
 (submitted: May 24, 2007)
400
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00478556
Other Study ID Numbers  ICMJE F070208011
Omnipaque vs Gastroview Oral ( Other Identifier: Department Name )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michelle McNamara, MD, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE GE Healthcare
Investigators  ICMJE
Principal Investigator: Michelle McNamara, MD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP