To compare two x-ray contrast agents on their safety and on how patients feel after injecetion into an artery.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000106-22-DE

Enrollment

250

Registered

2011-05-10

Start date

2011-09-01

Completion date

Unknown

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients that are referred to undergo a peripheral arterigraphy as part of their routine clinical care. MedDRA version: 14.1 Level: PT Classification code 10058049 Term: Administration site pain System Organ Class: 10018065 - General disorders and administration site conditions MedDRA version: 14.1 Level: PT Classification code 10022086 Term: Injection site pain System Organ Class: 10018065 - General disorders and administration site conditions MedDRA version: 14.1 Level: PT Classification co

Interventions

Trade Name: Visipaque 320 Product Name: Visipaque 320 mg I/ml Product Code: NA Pharmaceutical Form: Solution for injection INN or Proposed INN: iodixanol CAS Number: 92339112 Concentration unit: mg/m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1)The subject is over 18 years old. (2)Subjects are referred to undergo a peripheral arteriography as part of their routine clinical care. (3)The subject has provided signed and dated informed consent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 125 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 125

Exclusion criteria

Exclusion criteria: (1) The subject has known allergies to iodine or any prior history of adverse reaction to iodinated CM. (2) The subject received another administration of CM within 24 hours prior to baseline or is scheduled to receive one within 24 hours follow-up period. (3) The subject is pregnant or lactating. (4) The subject is taking metformin (e.g., Glucophage®) but is not willing or unable to discontinue at the time of the study procedure. Note: Metformin must not be taken at least 24 hours prior to the study procedures, withheld for at least 48 hours post-procedure, and restarted only after the subjects renal function has been evaluated and it is deemed safe to resume metformin. (5)The subject manifests thyrotoxicosis or is on dialysis. (6)The subject was previously included in this study. (7)The subject has unstable clinical condition where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate and compare overall patient comfort profile between an iso-osmolar contrast medium (IOCM), iodixanol 320 mg I/mL, and a low osmolar contrast medium (LOCM), iopamidol 370 mg I/mL, in patients undergoing peripheral arteriography. The patient discomfort is defined as a sensation of coldness or, heat and injection-associated pain experienced by the patient that is temporally associated with the injection/infusion of a contrast medium. ;Secondary Objective: •To evaluate and compare the impact of patient discomfort on image procedure and overall image quality. •To evaluate and compare the overall safety profile in terms of occurrence of adverse events within 24 hours following the contrast media CM administration. ;Primary end point(s): The primary safety endpoint is the comparison of the maximum intensity of patient discomfort as rated by the subjects during the overall peripheral arteriography following administration of iodixanol 320 mg I/mL versus iopamidol 370 mg I/mL. The intensity of the sensation of coldness or heat and injection associated pain after each injection will be rated separately by the subject using a scale of 0-10. Patient discomfort (i.e. pain, heat or coldness) score/category: –Subjects rate maximum intensity of the sensations of coldness, heat and pain on a scale of 0 -10. –Intensity categories: none = 0; mild= 1-3, Moderate = 4-7; severe = 8-10. –The overall patient discomfort is defined as the maximum of the individual discomfort ratings (i.e., pain, warmth or coldness). ;Timepoint(s) of evaluation of this end point: The primary end point will be evaluted up to 10 minutes after injection. Other safety assessments up til 24 hours after injection.	—

Measure

Time frame

Main Objective: To evaluate and compare overall patient comfort profile between an iso-osmolar contrast medium (IOCM), iodixanol 320 mg I/mL, and a low osmolar contrast medium (LOCM), iopamidol 370 mg I/mL, in patients undergoing peripheral arteriography. The patient discomfort is defined as a sensation of coldness or, heat and injection-associated pain experienced by the patient that is temporally associated with the injection/infusion of a contrast medium. ;Secondary Objective: •To evaluate and compare the impact of patient discomfort on image procedure and overall image quality. •To evaluate and compare the overall safety profile in terms of occurrence of adverse events within 24 hours following the contrast media CM administration. ;Primary end point(s): The primary safety endpoint is the comparison of the maximum intensity of patient discomfort as rated by the subjects during the overall peripheral arteriography following administration of iodixanol 320 mg I/mL versus iopamidol 370 mg I/mL. The intensity of the sensation of coldness or heat and injection associated pain after each injection will be rated separately by the subject using a scale of 0-10. Patient discomfort (i.e. pain, heat or coldness) score/category: –Subjects rate maximum intensity of the sensations of coldness, heat and pain on a scale of 0 -10. –Intensity categories: none = 0; mild= 1-3, Moderate = 4-7; severe = 8-10. –The overall patient discomfort is defined as the maximum of the individual discomfort ratings (i.e., pain, warmth or coldness). ;Timepoint(s) of evaluation of this end point: The primary end point will be evaluted up to 10 minutes after injection. Other safety assessments up til 24 hours after injection.

—

Secondary

Measure	Time frame
Secondary end point(s): Frequency of subjects with patient discomfort following intra-arterial administration of either iodixanol 320 mg I/mL or iopamidol 370 mg I/mL for peripheral arteriography.;Timepoint(s) of evaluation of this end point: The primary end point will be evaluted up to 10 minutes after injection. Other safety assessments up til 24 hours after injection.	—

Countries

Germany, Spain, United Kingdom, United States

Contacts

Public ContactRegulatory Affairs

GE Healthcare Ltd and its affiliates

miriam.balstad@ge.com4723185125

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026