NCT01517594已完成不适用
Tolerability of Pentasa® Sachet in Patients With Ulcerative Colitis Under Conditions of Standard Practice in the Czech Republic
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 568
- 试验地点
- 30
- 主要终点
- verify the safety profile: measured by number of AEs/SAEs
研究概览
简要总结
Confirmation of safety profile
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •treatment of Ulcerative Colitis
排除标准
- •hypersensitivity to mesalazine
- •severe liver or renal impairment
结局指标
主要结局
verify the safety profile: measured by number of AEs/SAEs
时间窗: 12 months from patient recruitment
次要结局
- dosage: evaluate dosage level(12 months from patient recruitment)
研究者
研究点 (30)
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