Iodixanol Versus Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic Imaging of Abdomen/Pelvis

• Sponsor: GE Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01376089
• Collaborator: i3 Statprobe (Industry)
• Enrollment: 304
• Location: 1
• Arms: 2
• Duration (Months): 9.1
• Patients Per Site Per Month: 33.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Patient Comfort and Safety	Drug: Iodixanol; Drug: Iopamidol	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 304 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Official Title: 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
• Study Start Date: May 1, 2011
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm 1-Iodixanol	Drug: Iodixanol; Iodixanol 320 mg I/mL as a single iv. administration.; Other Names: Visipaque
Active Comparator: Arm 2-Iopamidol	Drug: Iopamidol; Comparator agent iopamidol (Isovue) 370 mg I/mL as a single iv. administration.; Other Names: Isovue

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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 Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GE Healthcare	Princeton	New Jersey	United States	08540

Sponsors and Collaborators

• GE Healthcare
• i3 Statprobe

Investigators

• Study Director: Lauren Lim, PharmD, GE Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GE Healthcare
• ClinicalTrials.gov Identifier: NCT01376089
• Other Study ID Numbers: GE-012-097
• First Posted: Jun 20, 2011
• Last Update Posted: Dec 19, 2013
• Last Verified: Nov 1, 2013

• Keywords provided by GE Healthcare: Safety

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Arm 1-Iodixanol	Arm 2-Iopamidol
Arm/Group Description	Subjects were injected with Iodixanol (Visipaque).	Subjects were injected with Iopamidol (Isovue).
Period Title: Overall Study
STARTED	151	148
COMPLETED	148	144
NOT COMPLETED	3	4

Baseline Characteristics

Arm/Group Title	Arm 1-Iodixanol	Arm 2-Iopamidol	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	151	148	299
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	91 60.3%	91 61.5%	182 60.9%
>=65 years	60 39.7%	57 38.5%	117 39.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.8 (15.23)	58.5 (15.02)	58.1 (15.10)
Sex: Female, Male (Count of Participants)
Female	68 45%	80 54.1%	148 49.5%
Male	83 55%	68 45.9%	151 50.5%
Region of Enrollment (participants) [Number]
United States	65 43%	62 41.9%	127 42.5%
Germany	45 29.8%	43 29.1%	88 29.4%
Spain	35 23.2%	35 23.6%	70 23.4%
United Kingdom	6 4%	8 5.4%	14 4.7%

Outcome Measures

1. Primary Outcome

Title	Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
Description	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.
Time Frame	Within 10 minutes post contrast administration

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1-Iodixanol (Visipaque)	Arm 2-Iopamidol (Isovue)
Arm/Group Description	Subjects injected with Visipaque contrast media. Number of subjects with any Moderate / Severe discomfort.	Subjects injected with Isovue contrast media. Number of subjects with any Moderate / Severe discomfort.
Measure Participants	151	147
Number [Number of Subjects with discomfort]	53	99

2. Primary Outcome

Title	Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
Description	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.
Time Frame	Within 10 minutes post contrast administration.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1-Iodixanol (Visipaque 320mgI/mL)	Arm 2-Iopamidol (Isovue 370mgI/mL)
Arm/Group Description	Subjects injected with Visipaque 320mgI/mL contrast media. Number of subjects with any Moderate / Severe discomfort.	Subjects injected with Isovue 370mgI/mL contrast media. Number of subjects with any Moderate / Severe discomfort.
Measure Participants	151	147
Discomfort of Cold	5	11
Discomfort of Heat	45	94
Discomfort of Pain	5	3

3. Secondary Outcome

Title	Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
Description	Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration.
Time Frame	Ten minutes post contrast administration.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1-Iodixanol (Visipaque 320mgI/mL)	Arm 2-Iopamidol (Isovue 370mgI/mL)
Arm/Group Description	Subjects injected with Visipaque 320mgI/mL contrast media.	Subject injected with Isovue 370mgI/mL contrast media.
Measure Participants	151	148
Image Quality was Excellent	144	133
Image Quality was Adequate	7	14
Image Quality was Poor	0	1

Adverse Events

Arm/Group Title	Arm 1-Iodixanol (Visipaque 320mgI/mL)		Arm 2-Iopamidol (Isovue 370mgI/mL)
Arm/Group Description	Subjects injected with Visipaque 320mgI/mL contrast media.		Subject injected with Isovue 370mgI/mL contrast media.
All Cause Mortality
	Arm 1-Iodixanol (Visipaque 320mgI/mL)		Arm 2-Iopamidol (Isovue 370mgI/mL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Arm 1-Iodixanol (Visipaque 320mgI/mL)		Arm 2-Iopamidol (Isovue 370mgI/mL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/151 (0%)		1/148 (0.7%)
Gastrointestinal disorders
Acute Appendicitis	0/151 (0%)	0	1/148 (0.7%)	1
Other (Not Including Serious) Adverse Events
	Arm 1-Iodixanol (Visipaque 320mgI/mL)		Arm 2-Iopamidol (Isovue 370mgI/mL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	121/151 (80.1%)		134/148 (90.5%)
Gastrointestinal disorders
Gastrointestinal	10/151 (6.6%)	10	10/148 (6.8%)	10
General disorders
General disorder: Feeling Cold	8/151 (5.3%)	8	8/148 (5.4%)	8
General Disorders: Feeling Hot	77/151 (51%)	77	92/148 (62.2%)	92
Administration Site Conditions: Injection Site Coldness	5/151 (3.3%)	5	9/148 (6.1%)	9
Administration Site Conditions: Injection Site Reaction	30/151 (19.9%)	30	32/148 (21.6%)	32
Nervous system disorders
Nervousness	13/151 (8.6%)	13	9/148 (6.1%)	9

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.