EUCTR2010-020303-69-NL进行中（未招募）不适用
Enzyme substitution in exocrine pancreatic insufficiency; Self administration against a fixed dose regimen. - SAPES
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Erasmus MC
- 入组人数
- 20
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
- •Patients who are considered for this trial:
- •-are older than 18 years.
- •-suffer from EPI caused by CP.
- •-Fecal elastase < 0.200 mg/g
- •-are using = 6 capsules of 25.000 FIP-E units of lipase per day.
- •-fecal fat-absorption < 85% without using enzymes.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The following are considered as exclusion criteria:
- •- Subjects who are unwilling or unable to understand and participate in the study and/or sign the informed consent.
- •-Any known gastro-intestinal disease or major gastrointestinal or pancreatic surgery that could potentially affect the intestinal absorption or metabolism of fat
- •-Gastroparesis of any aetiology
- •-Hypersensitivity to pork protein
- •-Acute pancreatitis
- •-Limited life-expectancy of = 6 months
- •-Malignancy of the pancreas
- •-Pregnancy/lactation
研究者
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