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

This study has been completed.
Sponsor:
Collaborator:
i3 Statprobe
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01475097
First received: November 3, 2011
Last updated: March 11, 2014
Last verified: March 2014
Results First Received: March 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator)
Condition: Drug Safety
Interventions: Drug: Iodixanol
Drug: Iopamidol

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The total number of subjects that started the study was 255. 2 subjects did not complete the study. Total number of subjects that completed the study was 253.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Iodixanol 320mgI/mL Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
Iopamidol 370mgI/mL Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.

Participant Flow:   Overall Study
    Iodixanol 320mgI/mL     Iopamidol 370mgI/mL  
STARTED     127     126  
COMPLETED     127     126  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Iodixanol 320mgI/mL Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
Iopamidol 370mgI/mL Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
Total Total of all reporting groups

Baseline Measures
    Iodixanol 320mgI/mL     Iopamidol 370mgI/mL     Total  
Number of Participants  
[units: participants]
  127     126     253  
Age  
[units: years]
Mean ± Standard Deviation
  64.5  ± 13.34     62.0  ± 15.30     63.2  ± 14.38  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     55     68     123  
>=65 years     72     58     130  
Gender  
[units: participants]
     
Female     49     45     94  
Male     78     81     159  
Region of Enrollment  
[units: participants]
     
United States     27     24     51  
Germany     38     39     77  
Spain     57     58     115  
United Kingdom     5     5     10  



  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Comparison of Overall Image Quality Between Iodixanol and Iopamidol in Patients Undergoing Peripheral Arteriography.   [ Time Frame: Within 10 minutes post contrast administration. ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide 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.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Debra Mansfield
Organization: GE Healthcare
phone: 609-514-6329
e-mail: dabra.mansfield@ge.com


No publications provided


Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01475097     History of Changes
Other Study ID Numbers: GE-012-098
Study First Received: November 3, 2011
Results First Received: March 11, 2014
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board
Germany: Federal Institute for Drugs and Medical Devices
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency