Confirmatory study of EN-P05 in patients with tube feeding.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- TTR
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, randomized, open-label, parallel group trial
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 20age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1)Patients needed enteral nutrition support.
- •(2)Patients able to stay at the study site from the day before the start of the run-in observation period until completion of post-dosing examination.
- •(3)Patients aged 20years old or more.
- •(4)Patients or the legal representative capable of giving informed consent to participate in the study of their own free will.
排除标准
- •(1) patients with a history of hypersensitivity to any ingredients of study drugs
- •(2) patients with a history of allergy to milk protein
- •(3) patients with ileus
- •(4) patients with no residual intestinal function
- •(5) patients with severe liver or renal dysfunction (example: acute or chronic renal failure, or cirrhosis)
- •(6) patients with abnormalities in carbohydrate metabolism including severe diabetes mellitus
- •(7) patients with congenital abnormalities in amino and metabolism
- •(8) patients with severe heart disease (example: myocardial infarction), severe hematological disorder (example: aplastic anemia), inflammatory bowel disease, pneumonia, serious diarrhea (example: frequent watery diarrhea), and patients with malignant tumor
- •(9) patients with a history of resection of tract (esophagus, stomach and intestines) within 1 year before registration, except for slight removal like polyp or appendectomy
- •(10) patients with difficulties in taking sufficient amount of blood for clinical trial
- •(11) patients participated in other clinical trials within 6 months before obtaining informed consent
- •(12) patients who are judged by investigator to be excluded
结局指标
主要结局
TTR
Student's t-tests and Wilcoxon test will be used between two arms for each parameter at each timepoint and be calculated 95% confidence interval. Number of patients who are within or without tolerance interval (the range from the minimum to the maximum values in the controll group) are counted at every timepoint, together with their rate.
RBP
Student's t-tests and Wilcoxon test will be used between two arms for each parameter at each timepoint and be calculated 95% confidence interval. Number of patients who are within or without tolerance interval (the range from the minimum to the maximum values in the controll group) are counted at every timepoint, together with their rate.
Tf
Student's t-tests and Wilcoxon test will be used between two arms for each parameter at each timepoint and be calculated 95% confidence interval. Number of patients who are within or without tolerance interval (the range from the minimum to the maximum values in the controll group) are counted at every timepoint, together with their rate.
次要结局
未报告次要终点