JPRN-C000000300已完成3 期
Z-206 Phase III Clinical Trial - Investigation on the remission-inducing effect in patients with Crohn's disease in active phase - - Z-206 Phase III Clinical Trial - Investigation on the remission-inducing effect in patients with Crohn's disease in active phase
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 16years-old 至 64years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)Patients to whom oral formulation of mesalazine of a dose exceeding 3 g/day was administered or oral formulation of salazosulfapyridine of a dose exceeding 6 g/day was administered within 7 days of the start of administration of this trial drug. 2)Patients to whom mesalazine enema or salazosulfapyridine suppository was given within 7 days of the start of administration of this clinical study drug. 3)Patients who took adrenal cortex hormone within 14 days before start of administration of clinical study drug. 4)Patients who were given metronidazole or ciprofloxacin within 14 days before start of administration of clinical study drug. 5)Patients who were administered immune-suppressing drugs within 90 days before start of administration of clinical study drug. 6)Patients who were administered infliximab (anti-human TNF-alpha monoclonal antibody) within 90 days before start of administration of clinical study drug. 7)Patients with history of drug hypersensitivity to mesalazine formulation and drugs of salicylic acid groups. 8)Patients with history of enterectomy for Crohn's disease. 9)Patients with active anal lesion (Patients with anal stenosis that affect number of defecation, or patients with anal fistula accompanied by fever) 10)Patients treated by total parenteral nutrition method. 11)Patients with liver disease or kidney disease (Each clinician will judge the presence or absence of liver disease or kidney disease). 12)Patients with serious cardiovascular disease, hemodyscrasia or lung disease, or patients with history of serious cardiovascular disease, hemodyscrasia, lung disease. 13)Patients with malignant tumors 14)Patients who are pregnant, breast-feeding or desire to become pregnant during this trial period 15)Patients who were administered some kinds of clinical study drug within 6 months before obtaining informed consent. 16)Patients whom principle investigator or co-investigator judged unfit to participate in this trial.
研究者
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