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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: June 3, 2014
Last verified: June 2014
Results First Received: March 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator)
Condition: Drug Safety
Interventions: Drug: Iodixanol
Drug: Iopamidol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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 Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Total of 255 subjects enrolled in this study. 2 subjects discontinued the study prior to contrast administration. Therefore, 253 subjects completed the study.

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   128   127 
COMPLETED   127   126 
NOT COMPLETED   1   1 
Protocol Violation                1                1 



  Baseline Characteristics
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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.
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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 
Overall Participants Analyzed 
[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
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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


  Limitations and Caveats
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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
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  More Information
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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.


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



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: June 3, 2014