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| Name | Class |
|---|---|
| i3 Statprobe | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1-Iodixanol | Other |
| |
| Arm 2-Iopamidol | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iodixanol | Drug | Iodixanol 320 mg I/mL as a single iv. administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | 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. | Within 10 minutes post contrast administration |
| Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | 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. | Within 10 minutes post contrast administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration. | Ten minutes post contrast administration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lauren Lim, PharmD | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GE Healthcare | Princeton | New Jersey | 08540 | United States |
A total of 304 subjects were enrolled in this study, however, 5 subjects did not receive contrast media due to administrative and /or technical reason leaving 299 subjects included in the analysis.
A total of 304 subjects were enrolled in this study, however, 5 subjects did not receive contrast media due to administrative and /or technical reason leaving 299 subjects included in the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1-Iodixanol | Subjects were injected with Iodixanol (Visipaque). |
| FG001 | Arm 2-Iopamidol | Subjects were injected with Iopamidol (Isovue). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1-Iodixanol | |
| BG001 | Arm 2-Iopamidol | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | 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. | Posted | Number | Number of Subjects with discomfort | Within 10 minutes post contrast administration |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1-Iodixanol (Visipaque 320mgI/mL) | Subjects injected with Visipaque 320mgI/mL contrast media. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Appendicitis | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Lim, PharmD | GE Healthcare | 1-626-356-1937 | lauren.lim@ge.com |
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| ID | Term |
|---|---|
| C044834 | iodixanol |
| D007479 | Iopamidol |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| Iopamidol | Drug | Comparator agent iopamidol (Isovue) 370 mg I/mL as a single iv. administration. |
|
|
Total of all reporting groups
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | 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. | Posted | Number | Number of Subjects with discomfort | Within 10 minutes post contrast administration. |
|
|
|
| Secondary | Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. | Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration. | Posted | Number | Number of subject images | Ten minutes post contrast administration. |
|
|
|
| 0 |
| 151 |
| 121 |
| 151 |
| EG001 | Arm 2-Iopamidol (Isovue 370mgI/mL) | Subject injected with Isovue 370mgI/mL contrast media. | 1 | 148 | 134 | 148 |
| General disorder: Feeling Cold | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Nervousness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| General Disorders: Feeling Hot | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Administration Site Conditions: Injection Site Coldness | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
| Administration Site Conditions: Injection Site Reaction | General disorders | MedDRA 14.0 | Non-systematic Assessment |
|
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| Discomfort of Pain |
|
| Image Quality was Poor |
|