Who is sponsoring NCT01376089?

NCT01376089 is sponsored by GE Healthcare.

What condition does NCT01376089 study?

NCT01376089 studies Patient Comfort and Safety.

What drugs are being tested in NCT01376089?

Interventions: Iodixanol, Iopamidol.

What is the status of NCT01376089?

NCT01376089 is currently COMPLETED.

Last reviewed 2013-11-05 · How we verify

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

NCT01376089 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	GE Healthcare
Phase	Phase 4
Status	COMPLETED
Enrolment	304
Start date	2011-05
Completion	2012-02

Conditions

Patient Comfort and Safety

Interventions

Iodixanol
Iopamidol

Primary outcomes

Frequency of Subjects With Moderate/Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. — Within 10 minutes post contrast administration
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.
Frequency of Subjects With Moderate / Severe Discomfort When Undergoing Contrast-Enhanced Computed Tomographic (CECT) Imaging of the Abdomen/Pelvis. — Within 10 minutes post contrast administration.
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.

Countries

United States