At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 304 enrolled
Drug / intervention
Iodixanol +1 moredrug
Likely dose
Iodixanol 320 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating Iodixanol and Iopamidol for Patient Comfort and Safety. Completed, enrolled 304 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPatient Comfort and Safety
CountriesUnited States
Collaboratorsi3 Statprobe
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2011
First PostedJun 2011
Primary CompletionOct 2011
Study CompletionFeb 2012
TodayJul 2026
First PostedJun 20, 2011
Enrollment StartMay 1, 2011
Primary CompletionOct 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.0 years ago
Interventions
Iodixanoldrug
Iodixanol 320 mg I/mL as a single iv. administration.
Iopamidoldrug
Comparator agent iopamidol (Isovue) 370 mg I/mL as a single iv. administration.