NCT01376089

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

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 Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 304 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patient Comfort and Safety

Interventions

Type	Name	Description
DRUG	Iodixanol	Iodixanol 320 mg I/mL as a single iv. administration.
DRUG	Iopamidol	Comparator agent iopamidol (Isovue) 370 mg I/mL as a single iv. administration.

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-10-01
• Completion: 2012-02-01
• First posted: 2011-06-20
• Last updated: 2013-12-19
• Results posted: 2013-12-19

Locations

1 site across 1 country: United States