NCT06058442招募中3 期
The Pancreatic Enzymes After Gastrectomy Trial
University of Leipzig18 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2024年1月24日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 188
- 试验地点
- 18
- 主要终点
- Disease specific quality of life (QOL)
研究概览
简要总结
This trial evaluates the effects (e.g. on quality of life, weight) of NORTASE® compared to standard care of patients who have undergone gastrectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastrectomy (total and partial distal); at least > 50 % of the stomach must be resected
- •Age 18 or older
- •Written informed consent
排除标准
- •Indication for pancreas enzyme therapy
- •Gastrectomy with palliative intention
- •UICC (Union for International Cancer Control) Stage IV gastric malignancy
- •Malnutrition of other aetiology
- •Life expectancy < 12 months
- •Known lactose intolerance
- •Known hereditary galactose intolerance
- •Patients on alpha-glucosidase inhibitors (AGIs)
- •Acute pancreatitis
- •Acute episode of chronic pancreatitis
- •Known hypersensitivity to moulds (mould allergy) or any other ingredient of NORTASE®
- •Participation in competing interventional trials may be allowed under circumstances
- •Patients under legal supervision or guardianship
- •Patients who are dependent on the investigator or the medical staff of the trial team or the coordinating investigator or the sponsor
- •Fertile women (within two years of their last menstruation) without appropriate contraceptive measures (implanon, injections, oral contraceptives, intrauterine devices, partner with vasectomy) while participating in the trial
- •Pregnant or nursing women
- •Suspected lack of compliance
- •Patients who were already enrolled in the trial
研究组 & 干预措施
NORTASE®
Experimental
干预措施: NORTASE® (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Disease specific quality of life (QOL)
时间窗: 6 months
This is the physical sub-score from the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC-QLQ-C30) and ranges from 0 (lowest physical functioning) to 100 (highest physical functioning).
次要结局
- Vitamin K(6 months)
- HbA1c(6 months)
- Vitamin B12(6 months)
- Serum haemoglobin(6 months)
- Albumin(6 months)
- Glucose(6 months)
- Cholesterol(6 months)
- Nutritional supplementation or weight loss(6 months)
- Weight(6 months)
- Vitamin A(6 months)
- Vitamin D(6 months)
- Vitamin E(6 months)
- Total protein(6 months)
研究者
Albrecht Hoffmeister
Prof. Dr. med.
University of Leipzig
研究点 (18)
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