NL-OMON35552招募中不适用
Enzyme substitution in exocrine pancreatic insufficiency; Self administration against a fixed dose regimen. - SAPES
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Patients 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.
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 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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