Patients needed enteral nutrition support with tube feeding.
Conditions
Sponsors
EN Otsuka Pharmaceutical Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (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.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy TTR, RBP, Tf Number of patients who are within or without tolerance interval (the range from the minimum to the maximum values in the controll grop) are counted at every timepoint,together with their rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy TP, Alb, T-cho, TG, Na, K, Cl, Ca, Fe, Zn, Mn, Se, F-T3,F-T4,Cu, Cr, carnitine Number of patients who are within or without tolerance interval (the range from the minimum to the maximum values in the controll grop) are counted at every timepoint,together with their rate. | — |
Countries
Japan
Outcome results
None listed