Comparing Patient Comfort and Safety Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography

• Sponsor: GE Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01475097
• Collaborator: i3 Statprobe (Industry)
• Enrollment: 255
• Location: 1
• Arms: 2
• Duration (Months): 16.1
• Patients Per Site Per Month: 15.9

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate and compare overall patient comfort profile between an 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 arteriography of peripheral arteries.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 255 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 Peripheral Arteriography
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Feb 1, 2013
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active Arm	Drug: Iodixanol; Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.; Other Names: Visipaque
Active Comparator: Comparator Arm	Drug: Iopamidol; Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.; Other Names: Isovue

Outcome Measures

Primary Outcome Measures

1. Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography [Within 10 minutes post contrast administration.]

   The number of subjects experiencing overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.

Secondary Outcome Measures

1. Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography. [Within 10 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 peripheral arteriography 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 or lactating.

• 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: NCT01475097
• Other Study ID Numbers: GE-012-098
• First Posted: Nov 21, 2011
• Last Update Posted: Jun 11, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by GE Healthcare: AE - Adverse event; Arteriography; IA - Intra-arterial; IOCM - Iso-Osmolar Contrast Medium; LOCM - Low-Osmolar Contrast Medium; Patient Comfort; Body Image Disturbance; Patient

Study Results

Participant Flow

Recruitment Details	255 subjects were enrolled in this study. Two (2) subjects did not complete the study. Total number of subjects that completed the study was 253.
Pre-assignment Detail	Total of 255 subjects enrolled in this study. 2 subjects discontinued the study prior to contrast administration. Therefore, 253 subjects completed the study.

Arm/Group Title	Iodixanol 320mgI/mL	Iopamidol 370mgI/mL
Arm/Group Description	Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.	Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
Period Title: Overall Study
STARTED	128	127
COMPLETED	127	126
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Iodixanol 320mgI/mL	Iopamidol 370mgI/mL	Total
Arm/Group Description	Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.	Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.	Total of all reporting groups
Overall Participants	127	126	253
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.5 (13.34)	62.0 (15.30)	63.2 (14.38)
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	55 43.3%	68 54%	123 48.6%
>=65 years	72 56.7%	58 46%	130 51.4%
Sex: Female, Male (Count of Participants)
Female	49 38.6%	45 35.7%	94 37.2%
Male	78 61.4%	81 64.3%	159 62.8%
Region of Enrollment (participants) [Number]
United States	27 21.3%	24 19%	51 20.2%
Germany	38 29.9%	39 31%	77 30.4%
Spain	57 44.9%	58 46%	115 45.5%
United Kingdom	5 3.9%	5 4%	10 4%

Outcome Measures

1. Primary Outcome

Title	Subjects Experiencing Discomfort When Undergoing Peripheral Arteriography
Description	The number of subjects experiencing overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.
Time Frame	Within 10 minutes post contrast administration.

Outcome Measure Data

Analysis Population Description

249 subjects completed assessments, for overall discomfort, heat or pain between Iodixanol and Iopamidol during the diagnostic phase of imaging.124 subjects received Iodixanol and 125 subjects received Iopamidol.

Arm/Group Title	Iodixanol 320mgI/mL	Iopamidol 370mgI/mL
Arm/Group Description	Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.	Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
Measure Participants	124	125
Discomfort	53 41.7%	92 73%
Heat	48 37.8%	82 65.1%
Pain	5 3.9%	21 16.7%

2. Secondary Outcome

Title	Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography.
Description	Overall Image Quality rated as 'Excellent, Adequate or Poor' by radiologists blinded to the contrast administration.
Time Frame	Within 10 minutes post contrast administration.

Outcome Measure Data

Analysis Population Description

A recruitment error occurred with a subject in each treatment group. Therefore, the subject's efficacy data were excluded from this efficacy analysis. This resulted in a total of 126 Iodixanol subjects and a total 125 Iopamidol subjects were used in the imaging analysis.

Arm/Group Title	Iodixanol 320mgI/mL	Iopamidol 370mgI/mL
Arm/Group Description	Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.	Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
Measure Participants	126	125
Excellent	109 85.8%	103 81.7%
Adequate	16 12.6%	19 15.1%
Poor	1 0.8%	3 2.4%

Adverse Events

Arm/Group Title	Iodixanol 320mgI/mL		Iopamidol 370mgI/mL
Arm/Group Description	Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.		Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
All Cause Mortality
	Iodixanol 320mgI/mL		Iopamidol 370mgI/mL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Iodixanol 320mgI/mL		Iopamidol 370mgI/mL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/127 (1.6%)		2/126 (1.6%)
Cardiac disorders
Acute Myocardial Infarction	2/127 (1.6%)	2	0/126 (0%)	0
Ventricular Fibrillation	0/127 (0%)	0	1/126 (0.8%)	1
Gastrointestinal disorders
Retroperitoneal Hemorrhage	0/127 (0%)	0	1/126 (0.8%)	1
General disorders
Vessel Puncture Site Hematoma	1/127 (0.8%)	1	0/126 (0%)	0
Respiratory, thoracic and mediastinal disorders
Hypoxia	0/127 (0%)	0	1/126 (0.8%)	1
Vascular disorders
Hemorrhage from femoral common artery	0/127 (0%)	0	1/126 (0.8%)	1
Hypovolemic Shock	0/127 (0%)	0	1/126 (0.8%)	1
Other (Not Including Serious) Adverse Events
	Iodixanol 320mgI/mL		Iopamidol 370mgI/mL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/127 (11.8%)		3/126 (2.4%)
Eye disorders
Photopsia	7/127 (5.5%)	7	1/126 (0.8%)	1
Nervous system disorders
Dizziness	8/127 (6.3%)	8	2/126 (1.6%)	2

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.