Trial Outcomes & Findings for Iodixanol Versus Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic Imaging of Abdomen/Pelvis (NCT NCT01376089)
NCT ID: NCT01376089
Last Updated: 2013-12-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
304 participants
Primary outcome timeframe
Within 10 minutes post contrast administration
Results posted on
2013-12-19
Participant Flow
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.
Participant milestones
| Measure |
Arm 1-Iodixanol
Subjects were injected with Iodixanol (Visipaque).
|
Arm 2-Iopamidol
Subjects were injected with Iopamidol (Isovue).
|
|---|---|---|
|
Overall Study
STARTED
|
151
|
148
|
|
Overall Study
COMPLETED
|
148
|
144
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Arm 1-Iodixanol
Subjects were injected with Iodixanol (Visipaque).
|
Arm 2-Iopamidol
Subjects were injected with Iopamidol (Isovue).
|
|---|---|---|
|
Overall Study
Patient received no contrast media
|
3
|
4
|
Baseline Characteristics
Iodixanol Versus Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic Imaging of Abdomen/Pelvis
Baseline characteristics by cohort
| Measure |
Arm 1-Iodixanol
n=151 Participants
|
Arm 2-Iopamidol
n=148 Participants
|
Total
n=299 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
|
91 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
60 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Age Continuous
|
57.8 years
STANDARD_DEVIATION 15.23 • n=5 Participants
|
58.5 years
STANDARD_DEVIATION 15.02 • n=7 Participants
|
58.1 years
STANDARD_DEVIATION 15.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=5 Participants
|
62 participants
n=7 Participants
|
127 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
45 participants
n=5 Participants
|
43 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 10 minutes post contrast administrationNumber 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.
Outcome measures
| Measure |
Arm 1-Iodixanol (Visipaque)
n=151 Participants
Subjects injected with Visipaque contrast media. Number of subjects with any Moderate / Severe discomfort.
|
Arm 2-Iopamidol (Isovue)
n=147 Participants
Subjects injected with Isovue contrast media. Number of subjects with any Moderate / Severe discomfort.
|
|---|---|---|
|
Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
|
53 Number of Subjects with discomfort
Interval 27.49 to 42.71
|
99 Number of Subjects with discomfort
Interval 59.77 to 74.93
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Arm 1-Iodixanol (Visipaque)
n=151 Participants
Subjects injected with Visipaque contrast media. Number of subjects with any Moderate / Severe discomfort.
|
Arm 2-Iopamidol (Isovue)
n=147 Participants
Subjects injected with Isovue contrast media. Number of subjects with any Moderate / Severe discomfort.
|
|---|---|---|
|
Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
Discomfort of Cold
|
5 Number of Subjects with discomfort
Interval 0.46 to 6.17
|
11 Number of Subjects with discomfort
Interval 3.23 to 11.74
|
|
Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
Discomfort of Heat
|
45 Number of Subjects with discomfort
Interval 22.51 to 37.1
|
94 Number of Subjects with discomfort
Interval 56.18 to 71.71
|
|
Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
Discomfort of Pain
|
5 Number of Subjects with discomfort
Interval 0.46 to 6.17
|
3 Number of Subjects with discomfort
Interval 0.0 to 4.33
|
SECONDARY outcome
Timeframe: Ten minutes post contrast administration.Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration.
Outcome measures
| Measure |
Arm 1-Iodixanol (Visipaque)
n=151 Participants
Subjects injected with Visipaque contrast media. Number of subjects with any Moderate / Severe discomfort.
|
Arm 2-Iopamidol (Isovue)
n=148 Participants
Subjects injected with Isovue contrast media. Number of subjects with any Moderate / Severe discomfort.
|
|---|---|---|
|
Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
Image Quality was Poor
|
0 Number of subject images
|
1 Number of subject images
|
|
Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
Image Quality was Excellent
|
144 Number of subject images
|
133 Number of subject images
|
|
Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
Image Quality was Adequate
|
7 Number of subject images
|
14 Number of subject images
|
Adverse Events
Arm 1-Iodixanol (Visipaque 320mgI/mL)
Serious events: 0 serious events
Other events: 121 other events
Deaths: 0 deaths
Arm 2-Iopamidol (Isovue 370mgI/mL)
Serious events: 1 serious events
Other events: 134 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1-Iodixanol (Visipaque 320mgI/mL)
n=151 participants at risk
Subjects injected with Visipaque 320mgI/mL contrast media.
|
Arm 2-Iopamidol (Isovue 370mgI/mL)
n=148 participants at risk
Subject injected with Isovue 370mgI/mL contrast media.
|
|---|---|---|
|
Gastrointestinal disorders
Acute Appendicitis
|
0.00%
0/151
|
0.68%
1/148 • Number of events 1
|
Other adverse events
| Measure |
Arm 1-Iodixanol (Visipaque 320mgI/mL)
n=151 participants at risk
Subjects injected with Visipaque 320mgI/mL contrast media.
|
Arm 2-Iopamidol (Isovue 370mgI/mL)
n=148 participants at risk
Subject injected with Isovue 370mgI/mL contrast media.
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal
|
6.6%
10/151 • Number of events 10
|
6.8%
10/148 • Number of events 10
|
|
General disorders
General disorder: Feeling Cold
|
5.3%
8/151 • Number of events 8
|
5.4%
8/148 • Number of events 8
|
|
Nervous system disorders
Nervousness
|
8.6%
13/151 • Number of events 13
|
6.1%
9/148 • Number of events 9
|
|
General disorders
General Disorders: Feeling Hot
|
51.0%
77/151 • Number of events 77
|
62.2%
92/148 • Number of events 92
|
|
General disorders
Administration Site Conditions: Injection Site Coldness
|
3.3%
5/151 • Number of events 5
|
6.1%
9/148 • Number of events 9
|
|
General disorders
Administration Site Conditions: Injection Site Reaction
|
19.9%
30/151 • Number of events 30
|
21.6%
32/148 • Number of events 32
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place