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
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