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
- 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 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.
结局指标
主要结局
TTR
Number of patients who are within or without tolerance interval (the range from the minimum to the maximum values in the control group) are counted at every timepoint, together with their rate.
RBP
Number of patients who are within or without tolerance interval (the range from the minimum to the maximum values in the control group) are counted at every timepoint, together with their rate.
Tf
Number of patients who are within or without tolerance interval (the range from the minimum to the maximum values in the control group) are counted at every timepoint, together with their rate.
次要结局
- Alb
- T-cho
- TG
- Na
- TP
- K
- Cl
- Ca
- Fe
- Zn
- Mn
- Se
- F-T3
- F-T4
- Cu
- Cr
- carnitine
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Confirmatory study of EN-P05 in patients with tube feeding.jRCT2080223361EN Otsuka Pharmaceutical Co.,Ltd.110
已完成
不适用
Confirmatory study of EN-P09 in patients with enteral tube feeding.jRCT2031210285EN Otsuka Pharmaceutical Co., Ltd.110
已完成
3 期
Confirmatory study of EN-P09 in patients with enteral tube feeding.JPRN-jRCT2031210285Maruyama Michio110
未知
1 期
Phase 1/2 study of NS-065/NCNP-01 in patients with Duchenne muscular dystrophyDuchenne muscular dystrophyJPRN-jRCT2080223236IPPON SHINYAKU CO., LTD.16
未知
2 期
Phase 1/2 study of NS-065/NCNP-01 in patients with Duchenne muscular dystrophyDuchenne muscular dystrophyjRCT2080223236NIPPON SHINYAKU CO., LTD.16