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临床试验/EUCTR2019-004940-31-DK
EUCTR2019-004940-31-DK进行中(未招募)1 期

Effect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trial

Terese Katzenstein0 个研究点目标入组 30 人开始时间: 2020年3月24日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
30

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Outpatient adults of legal age (=18 years)
  • with cystic fibrosis and pancreatic
  • insufficiency and who takes enzyme
  • replacement therapy (Creon®) with every fat
  • containing meal of the day.
  • - The patients must be able to physically
  • attend the planned trial days once a month.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 29
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 1

排除标准

  • - Acutely ill outpatient and inpatient CF
  • patients with other disease of impact on
  • primary outcome (i.e. obstipation that
  • requires treatment and/or acute lung
  • exacerbation).
  • - Pregnancy.
  • - BMI below 18,5.
  • - Nonattendance from planned trial days without possibility of rescheduling within a week.

研究者

发起方
Terese Katzenstein

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