NCT01104753已完成不适用
Non-interventional Post Marketing Safety Study Confirming Efficacy and Safety of Pentasa Slow Release Tablets in Patients With Ulcerative Colitis in Common Clinical Practice
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 338
- 试验地点
- 23
- 主要终点
- Verify the safety profile
研究概览
简要总结
Confirmation of safety profile of Pentasa slow release tablets 500 mg in patients with ulcerative colitis (UC).
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
- •Patients suffering from ulcerative colitis
排除标准
- •Hypersensitivity to mesalazine, salicylates or to any excipient
- •Severe damage to liver or renal functions
结局指标
主要结局
Verify the safety profile
时间窗: 1 year
* Number of AEs/SAEs * Intensity and seriousness of reported AEs/SAEs
次要结局
未报告次要终点
研究者
研究点 (23)
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