A Phase 4 Randomized, Double-blind Study Comparing Patient Comfort and Safety Between Iodixanol 320 mg I/mL and Iopamidol 370 mg I/mL in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis
| Registry | NCT01376089 |
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| Status | Completed |
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| Phase | Phase 4 |
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| Study type | Interventional; randomized, parallel, masking: double |
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| Enrollment | 304 (Actual) |
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| Sponsor | GE Healthcare (Industry); collaborators: i3 Statprobe |
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| Conditions | Patient Comfort and Safety |
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| Interventions | Iodixanol, Iopamidol (Drug) |
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| Dates | start 2011-05-01, primary completion 2011-10-01, completion 2012-02-01, first posted 2011-06-20, last updated 2013-12-19 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Patient Comfort and Safety All trials of Iodixanol All trials of Iopamidol
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Arm 1-Iodixanol | Other | Drug: Iodixanol | |
| Arm 2-Iopamidol | Active comparator | Drug: Iopamidol | |
- Iodixanol (Drug), also known as Visipaque: Iodixanol 320 mg I/mL as a single iv. administration.
- Iopamidol (Drug), also known as Isovue: Comparator agent iopamidol (Isovue) 370 mg I/mL as a single iv. administration.
+Outcome measures
Primary outcomes
- Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. [Within 10 minutes post contrast administration]: Number of subjects experiencing any moderate (score of 4 - 7) to severe (score 8 - 10) discomfort for cold or heat or pain between Iodixanol and Iopamidol.
- Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. [Within 10 minutes post contrast administration.]: Number of subjects experiencing moderate (score of 4 -7) to severe (score of 8 - 10) discomfort for cold, heat or pain between Iodixanol and Iopamidol.
Secondary outcomes
- Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. [Ten minutes post contrast administration.]: Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration.
+Eligibility
Sex: All, ages: 18 Years to any
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.
+Posted results
Participant flow
| Milestone | Arm 1-Iodixanol | Arm 2-Iopamidol |
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| Started | 151 | 148 |
| Completed | 148 | 144 |
| Not completed | 3 | 4 |
Outcome results
- Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. (Primary), Number, Number of Subjects with discomfort: Arm 1-Iodixanol (Visipaque) 53 (27.49 to 42.71); Arm 2-Iopamidol (Isovue) 99 (59.77 to 74.93)
- Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. (Primary), Number, Number of Subjects with discomfort: Arm 1-Iodixanol (Visipaque 320mgI/mL) 5 (0.46 to 6.17); Arm 2-Iopamidol (Isovue 370mgI/mL) 11 (3.23 to 11.74)
- Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. (Secondary), Number, Number of subject images: Arm 1-Iodixanol (Visipaque 320mgI/mL) 144; Arm 2-Iopamidol (Isovue 370mgI/mL) 133
Adverse events
| Arm | Deaths | Serious adverse events | Other adverse events |
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| Arm 1-Iodixanol (Visipaque 320mgI/mL) | 0 | 0/151 (0.0%) | 121/151 (80.1%) |
| Arm 2-Iopamidol (Isovue 370mgI/mL) | 0 | 1/148 (0.7%) | 134/148 (90.5%) |
Serious adverse events by term
| Term | Organ system | Arm 1-Iodixanol (Visipaque 320mgI/mL) | Arm 2-Iopamidol (Isovue 370mgI/mL) |
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| Acute Appendicitis | Gastrointestinal disorders | 0/151 | 1/148 |
Other adverse events by term
| Term | Organ system | Arm 1-Iodixanol (Visipaque 320mgI/mL) | Arm 2-Iopamidol (Isovue 370mgI/mL) |
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| Gastrointestinal | Gastrointestinal disorders | 10/151 | 10/148 |
| General disorder: Feeling Cold | General disorders | 8/151 | 8/148 |
| Nervousness | Nervous system disorders | 13/151 | 9/148 |
| General Disorders: Feeling Hot | General disorders | 77/151 | 92/148 |
| Administration Site Conditions: Injection Site Coldness | General disorders | 5/151 | 9/148 |
| Administration Site Conditions: Injection Site Reaction | General disorders | 30/151 | 32/148 |
+Locations (1)
| Facility | City | Country | Status |
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| GE Healthcare | Princeton, New Jersey | United States | |
+Investigators