JPRN-jRCT2080222575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
- 112
研究概览
简要总结
EN-P05 was not considered to be a nutrition support formula similar to DA-8902, because the proportion of patients who were out of tolerance interval in TTR among the primary outcome was over 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 with tube feeding.
- •(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 ileus.
- •(2)Patients with severe intestinal dysfunction or loss of intestinal function.
- •(3)Patients with congenital abnormalities in amino and metabolism.
- •(4)Patients with a history of hypersensitivity to any ingredients of study drugs.
- •(5)Patients who are pregnant or hope for pregnancy.
- •(6)Patients with severe heart disease , severe hematological disorder , severe renal dysfunction, severe liver dysfunction, and malignant tumor.
- •(7)Patients with heart failure associated with nausea, vomiting, and diarrhea.
- •(8)Patients with acute nephritis, nephrosis or end-stage renal failure that require strict protein and electrolyte restrictions.
- •(9)Patients with abnormalities in carbohydrate metabolism including severe diabetes mellitus.
- •(10)Patients who are not expected to take an enteral nutrition for more than 10 days prior to study drug administration.
- •(11)Patients with a surgical history of esophagus, stomach, intestines, liver, or pancreas resection except for slight resection such as polyp, appendectomy, gastrostomy, nissen fundoplication.
- •(12)Patients with chronic diarrhea such as inflammatory bowel disease.
- •(13)Patients with pneumonia.
- •(14)Patients with difficulties in taking sufficient amount of blood for clinical trial.
- •(15)Patients participated in other clinical trials within 6 months before obtaining informed consent.
- •(16)Patients who are judged by investigator to be excluded.
研究者
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