EUCTR2005-004854-29-IT进行中（未招募）不适用
One week double-blind, randomized, placebo-controlled, parallel-group, multi-center study with Creon 25.000 Minimicrospheres in subject with pancreatic exocrine insufficiency after pancreatic surgery, followed by an open-label long-term extension of 1 year. - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 54
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
- •1. Subject must be #8805; 18 years. 2. Pancreatic exocrine insufficiency has to be proven after pancreatectomy by a pancreatic function test: human feacal elastase <50; in medical history or to be done at screening visit. 3. Subjects after pancreatic surgery (partial or total pancreatic resection). 4. Pancreatic surgery was at least 6 months prior to start of the study 5. Subjects in a stable situation after pancreatic surgery; Karnofsky index #8805; 70 6. Subjects with pancreatic resection due to cancer must have finalized adjuvant Chemotherapy 7. Females must be non-lactating and either be of non-childbearing potential (i.e, sterilized via hysterectomy or bilateral tubal ligation or at least 1 year postmenopausal) or if of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (IUD) or use birth control pills or equivalent injectable contraceptive. The subject must have been practicing the selected method of birth control for at least 3 months prior to visit 1 (day -14).
- •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
- •1. Unwillingness to participate and/or no signed informed consent 2. Subjects with recurrent tumours 3. Subjects with pancreatic surgery due to acute necrotizing pancreatitis. 4. Investigational drug intake within 30 days prior to the study entry 5. Ileus or acute abdomen 6. Current excessive intake of alcohol or drug abuse 7. Hypersensitivity to porcine proteins / pancreatin
研究者
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