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临床试验/NCT01220453
NCT01220453已完成不适用

Compliance and Efficacy in the Use of PICOPREP® for Bowel Cleansing

Ferring Pharmaceuticals3 个研究点 分布在 1 个国家目标入组 2,165 人开始时间: 2010年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2,165
试验地点
3
主要终点
Documentation of the use of PICOPREP® in every day practice

研究概览

简要总结

The present trial is aimed to document efficacy (bowel cleanliness), acceptance and tolerability as well as patient comfort in the use of the new bowel cleansing product PICOPREP® in every day practice. In particular, it should be evaluated, whether bowel cleanliness, acceptance, tolerability and patient comfort are affected by specific practice procedures, changes in dose etc.

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

入选标准

  • Patients receiving PICOPREP® for bowel evacuation prior to endoscopy or surgery
  • Patients who have been informed about the NIS and have given their written consent for participation

排除标准

  • Patients in which prescription of PICOPREP® is contraindicated

结局指标

主要结局

Documentation of the use of PICOPREP® in every day practice

时间窗: 2 days

Will evaluate efficacy (bowel cleanliness), compliance, acceptance, tolerability and patient comfort

次要结局

  • Documentation of patient satisfaction after bowel cleansing(2 days)
  • Documentation of examiner satisfaction after colonoscopy(2 days)
  • Identification of patient groups in which bowel cleansing is more difficult due to concomitant diseases or other conditions (risk groups)(2 days)
  • Tolerability: frequency and severity of adverse events(2 days)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (3)

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Compliance and Efficacy in the Use of PICOPREP® | 临床试验