Z-206 Phase III Clinical Trial - Investigation on the remission-maintaining effect in patients with ulcerative colitis in remission phase - - Z-206 Phase III Clinical Trial - Investigation on the remission-maintaining effect in patients with ulcerative colitis in remission phase

Zeria Pharmaceutical Co.,LTD.0 个研究点目标入组 120 人开始时间: 2005年11月21日最近更新: 2023年10月17日

适应症

试验速览

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•1)Patients who take adrenal corticosteroid (oral formulation, enemas, suppository, agents for hemorrhoidal problem, injectable solution) within 14 days before start of administration of clinical study drug. 2)Patients who are administered immune-suppressing drug before start of administration of clinical study drug within 90 day. 3)Patients who are treated by blood cell apheresis within 14 days before start of administration of clinical study drug. 4)Patients with history of drug hypersensitivity to mesalazine formulation and drugs of salicylic acid groups. 5)Patients with liver disease or kidney disease (Each clinician will judge the presence or absence of liver disease or kidney disease.) 6)Patients with serious cardiovascular disease, hemodyscrasia or lung disease, or patients with history of serious cardiovascular disease, hemodyscrasia or lung disease. 7)Patients with malignant tumor as complication. 8)Pregnants, females who suckles, or females who wish to become pregnant. 9)Patients who are administered some kinds of clinical study drug within 6 months before obtaining informed consent. The clinical study drug administered in

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