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Sponsored by: |
Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00165620 |
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.
Condition | Intervention | Phase |
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Lesion |
Drug: Iomeprole |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety Study |
Study Start Date: | November 2004 |
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteira:
Exclusion Criteria
Items that may affect the safety evaluation of E7337
General concerns relating to the safety of the subject.
5). 7) Patients with bronchial asthma 8) Patients with acute pancreatitis 9) Patients with macroglobulinemia 10) Patients with multiple myeloma 11) Patients with tetany 12) Patients with pheochromocytoma or who are suspected to be pheochromocytoma 13) Women of pregnant, childbearing potential, or lactating 14) Patients with a history of hypersensitivity to drug(s) 15) Patients with hypertension under medication 16) Patients with diabetes under medication 17) Patients with serious illness myasthenia 18) Patients judged to be ineligible for study entry by an investigator or subinvestigator for any other reasons
Japan | |
Kumamoto, Japan, :860-0811 | |
Japan, Osaka | |
Suita, Osaka, Japan, 565-0871 |
Study Director: | Koichi Tazawa | Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center |
Study ID Numbers: | E7337-J081-141 |
Study First Received: | September 12, 2005 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00165620 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Signs and Symptoms Liver Diseases |