JPRN-jRCT2080223361已完成3 期
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
- 100
研究概览
简要总结
EN-P05 was considered to be a nutrition support formula similar to OSN-001, because the proportion of patients who were out of tolerance interval in the primary outcome was within 10%.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 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
研究者
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