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Phase 4 N=300 Randomized Triple-blind Diagnostic

Omnipaque Versus Gastroview as Oral Contrast for Abdominal and Pelvic CT

Healthy

Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Jun 2010
Primary outcome: Primary: Preferred Contrast Agent — 25; 29; 117; 116 participants — p=<0.001

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Omnipaque (Drug); Gastroview (Drug)
Age
Adult, Older Adult · 19+ yrs
Sex
All
Sponsor
University of Alabama at Birmingham
Primary completion
Mar 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Preferred Contrast Agent
25; 29; 117; 116; 9; 4 <0.001 sig
SECONDARY
Bowel Opacification Score
8.57; 8.85 0.270

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00478556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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