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Confirmatory study of EN-P05 in patients with tube feeding.

Confirmatory study of EN-P05 in patients with tube feeding.

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There were no significant differences in the baseline characteristics (sex, age, body weight, BMI) in both groups. The cause of disease about enteral nutrition management were often observed nervous system disorders (amyotrophic lateral sclerosis, Parkinson's disease, multiple system atrophy etc.), congenital, familial, and hereditary disorders (cerebral palsy etc.) in both groups.

Fifty eight patients were enrolled in the EN-P05 group and 54 patients were enrolled in the DA-8902 group. One patient didn't lead to the study drug administration in EN-P05 group, the efficacy and safety analysis set included 57 patients in the EN-P05 group and 54 patients in the DA-8902-group, respectively.

The incidence of adverse events and adverse drug reactions were comparable in both groups.

The proportion of patients who were out of tolerance interval in TTR at the end of study drug administration was 12.7% (n=7/55). Whereas, the proportion of patients who were out of tolerance interval in RBP and Tf at the measurement time was within 10%, respectively. Tolerance interval: The range from the minimum to the maximum values in the DA-8902 group.

The proportion of patients who were out of tolerance interval in Fe and F-T4 was over 10% at the end of study drug administration. Tolerance interval: The range from the minimum to the maximum values in the DA-8902 group.

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%.

May. 10, 2019

https://www.iyaku.info/magazine/?id=1557451687-071221&sf=1&ca=2019&ca2=5

Undecided

EN Otsuka Pharmaceutical Co., Ltd.

en-kaihatsu@enotsuka.co.jp

EN Otsuka Pharmaceutical Co., Ltd.

en-kaihatsu@enotsuka.co.jp

completed

Sept. 22, 2014

Interventional

Multicenter, randomized, open-label, parallel group trial

treatment purpose

3

(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.

(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.

Both

Patients needed enteral nutrition support with tube feeding.

investigational material(s)
Generic name etc : EN-P05
INN of investigational material : -
Therapeutic category code : 325 Proteins, amino acid and preparations
Dosage and Administration for Investigational material : The standard dose of EN-P05 is decided 20-35 kcal/kg per day.

control material(s)
Generic name etc : DA-8902
INN of investigational material : -
Therapeutic category code : 325 Proteins, amino acid and preparations
Dosage and Administration for Investigational material : The standard dose of DA-8902 is decided 20-35 kcal/kg per day.

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.

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.

Aug. 12, 2014