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CompletedNCT01376089Updated Dec 19, 2013Results posted

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

A Phase 4 interventional study of Iodixanol and Iopamidol in Patient Comfort and Safety, sponsored by GE Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-19.

Sponsored by GE Healthcare · Phase 4 and Interventional

Phase
Phase 4
Study type
Interventional
Enrollment
304
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Patient Comfort and Safety

Keywords

  • Safety
03

In context

Lead sponsor

GE Healthcare is the lead sponsor of 168 studies on the registry; 19 are open to participants now.

Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 4
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
304 participants (actual)

Study arms

  • Other
    Arm 1-Iodixanol

    Drug: Iodixanol

  • Active comparator
    Arm 2-Iopamidol

    Drug: Iopamidol

Interventions

  • DrugIodixanol

    Iodixanol 320 mg I/mL as a single iv. administration.

    Also known as: Visipaque

  • DrugIopamidol

    Comparator agent iopamidol (Isovue) 370 mg I/mL as a single iv. administration.

    Also known as: Isovue

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 10 minutes post contrast administration

  2. 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.

    Time frame: Within 10 minutes post contrast administration.

Secondary outcomes

  1. 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.

    Time frame: Ten minutes post contrast administration.

07

Results

Posted Dec 19, 2013

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.

Participant flow — Overall Study
MilestoneArm 1-IodixanolArm 2-Iopamidol
Started151148
Completed148144
Not completed34
Withdrew: Patient received no contrast media34

Outcome measures

PrimaryFrequency 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.

Time frame:
Within 10 minutes post contrast administration
Reported as:
Number · Number of Subjects with discomfort
Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
Number of Subjects with discomfortArm 1-Iodixanol (Visipaque)Arm 2-Iopamidol (Isovue)
Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.53 (27.49 to 42.71)99 (59.77 to 74.93)
PrimaryFrequency 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.

Time frame:
Within 10 minutes post contrast administration.
Reported as:
Number · Number of Subjects with discomfort
Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis.
Number of Subjects with discomfortArm 1-Iodixanol (Visipaque 320mgI/mL)Arm 2-Iopamidol (Isovue 370mgI/mL)
Discomfort of Cold5 (0.46 to 6.17)11 (3.23 to 11.74)
Discomfort of Heat45 (22.51 to 37.10)94 (56.18 to 71.71)
Discomfort of Pain5 (0.46 to 6.17)3 (0.00 to 4.33)
SecondaryComparison 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.

Time frame:
Ten minutes post contrast administration.
Reported as:
Number · 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.
Number of subject imagesArm 1-Iodixanol (Visipaque 320mgI/mL)Arm 2-Iopamidol (Isovue 370mgI/mL)
Image Quality was Excellent144133
Image Quality was Adequate714
Image Quality was Poor01

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm 1-Iodixanol (Visipaque 320mgI/mL)—0/151 (0%)121/151 (80.1%)
Arm 2-Iopamidol (Isovue 370mgI/mL)—1/148 (0.7%)134/148 (90.5%)
Most frequent serious events
Most frequent serious events
EventArm 1-Iodixanol (Visipaque 320mgI/mL)Arm 2-Iopamidol (Isovue 370mgI/mL)
Acute AppendicitisGastrointestinal disorders0/1511/148
Most frequent other events
Most frequent other events
EventArm 1-Iodixanol (Visipaque 320mgI/mL)Arm 2-Iopamidol (Isovue 370mgI/mL)
General Disorders: Feeling HotGeneral disorders77/15192/148
Administration Site Conditions: Injection Site ReactionGeneral disorders30/15132/148
NervousnessNervous system disorders13/1519/148
GastrointestinalGastrointestinal disorders10/15110/148
Administration Site Conditions: Injection Site ColdnessGeneral disorders5/1519/148
General disorder: Feeling ColdGeneral disorders8/1518/148

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Arm 1-IodixanolArm 2-IopamidolTotal
<=18 years000
Between 18 and 65 years9191182
>=65 years6057117
Age Continuous
Age Continuous(years)Arm 1-IodixanolArm 2-IopamidolTotal
Mean57.8 ± 15.2358.5 ± 15.0258.1 ± 15.10
Sex: Female, Male
Sex: Female, Male(Participants)Arm 1-IodixanolArm 2-IopamidolTotal
Female6880148
Male8368151
Region of Enrollment
Region of Enrollment(participants)Arm 1-IodixanolArm 2-IopamidolTotal
United States6562127
Germany454388
Spain353570
United Kingdom6814
08

Study locations

1 site
  • GE Healthcare
    Princeton, New Jersey 08540, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01376089
Lead sponsor
GE Healthcare
Collaborators
i3 Statprobe
Responsible party
Sponsor
First posted
Jun 20, 2011
Start date
May 2011
Primary completion
Oct 2011
Completion
Feb 2012
Results posted
Dec 19, 2013
Last update
Dec 19, 2013

Study contacts

Lauren Lim, PharmD
study director · GE Healthcare

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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