A Randomized, Open, Parallel, Optimal Injection Rate-Finding Study for E7337 in Dynamic CT of the Liver in Patients With Liver Disease
NCT00165620 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2010-01-29
Summary
To establish the optimum injection rate for E7337 (Iomeron 350) in dynamic CT in patients who have hepatic lesions.The primary endpoint for efficacy is the contrast enhancement effect in the early arterial phase, and the primary safety endpoints are warming sensation and vascular pain.
Conditions
- Lesion
Interventions
- DRUG
-
Iomeprole
Sponsors & Collaborators
-
Eisai Limited
lead INDUSTRY
Principal Investigators
-
Koichi Tazawa · Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-11-30
- Primary Completion
- 2005-04-30
Countries
- Japan
Study Locations
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