Trial Outcomes & Findings for Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT (NCT NCT00478556)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

300 participants

Primary outcome timeframe

1 Day

Results posted on

2017-04-18

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Gastroview Group Patients will be given oral Gastroview (contrast) prior to Computerized Tomography (CT).	Omnipaque Group Patients ill be given oral Omnipaque (contrast) prior to Computerized Tomography (CT).
Overall Study STARTED	151	149
Overall Study COMPLETED	151	149
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gastroview n=151 Participants Oral Gastroview prior to CT	Omnipaque n=149 Participants Oral Omnipaque prior to CT	Total n=300 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	111 Participants n=5 Participants	96 Participants n=7 Participants	207 Participants n=5 Participants
Age, Categorical >=65 years	40 Participants n=5 Participants	53 Participants n=7 Participants	93 Participants n=5 Participants
Age, Continuous	56 years STANDARD_DEVIATION 15 • n=5 Participants	57 years STANDARD_DEVIATION 15 • n=7 Participants	57 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	56 Participants n=7 Participants	116 Participants n=5 Participants
Sex: Female, Male Male	91 Participants n=5 Participants	93 Participants n=7 Participants	184 Participants n=5 Participants
Region of Enrollment United States	151 participants n=5 Participants	149 participants n=7 Participants	300 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Day

Population: Analysis was per protocol

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

Outcome measures

Outcome measures
Measure	Gastroview n=151 Participants Oral Gastroview prior to CT	Omnipaque n=149 Participants Oral Omnipaque prior to CT
Preferred Contrast Agent Prefer Gastroview	25 participants	29 participants
Preferred Contrast Agent Prefer Omnipaque	117 participants	116 participants
Preferred Contrast Agent No Preference	9 participants	4 participants

SECONDARY outcome

Timeframe: Collected day of study

Population: per protocol - all patients had usable data

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.

Outcome measures

Outcome measures
Measure	Gastroview n=151 Participants Oral Gastroview prior to CT	Omnipaque n=149 Participants Oral Omnipaque prior to CT
Bowel Opacification Score	8.57 units on a scale Standard Deviation 1.96	8.85 units on a scale Standard Deviation 1.71

Adverse Events

Gastroview

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Omnipaque

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lisa Nelson

UAB Hospital Radiology

Phone: 205-934-4015

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place