Phase 4
N=299
Iodixanol Versus Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic Imaging of Abdomen/Pelvis
Patient Comfort and Safety
Bottom Line
View on ClinicalTrials.gov: NCT01376089 ↗Enrolled (actual)
299
Serious AEs
0.3%
Results posted
Dec 2013
Primary outcome: Primary: Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. — 53; 99 Number of Subjects with discomfort
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Iodixanol (Drug); Iopamidol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. |
53; 99 | — |
| PRIMARY Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. |
5; 11; 45; 94; 5; 3 | — |
| SECONDARY Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. |
144; 133; 7; 14; 0; 1 | — |
Summary
The purpose of this study is to evaluate and compare overall patient comfort profile between the Iso-osmolar contrast media (IOCM), iodixanol 320 mg I/mL, and a Low-osmolar contrast media (LOCM), iopamidol 370 mg I/mL in patients undergoing Contrast-Enhanced Computed Tomographic (CECT) imaging of the abdomen/pelvis.
Eligibility Criteria
Inclusion Criteria
- The subject is over 18 years old.
- Subjects are referred to undergo a CECT imaging of the abdomen/pelvis as part of their routine clinical care.
Exclusion Criteria
- The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM.
- The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within the 24 hour follow-up period.
- The subject is pregnant.
- The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to discontinue at the time of the study procedure.
- The subject manifests thyrotoxicosis or is on dialysis.
Data sourced from ClinicalTrials.gov (NCT01376089). 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.