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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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Among the baseline characteristics (sex, age, body weight, BMI) in both groups, there were significant differences in age, but there were no significant differences in the classification of age in ten-years increments, and the classification between under and over 65 of age. Thus, It did not seem to affect the assessment of efficacy and safety. The cause of disease about enteral nutrition management were often observed nervous system disorders (amyotrophic lateral sclerosis, cerebral infarction etc.) and congenital, familial and hereditary disorders (cerebral palsy etc.) in both groups.

Fifty patients were enrolled in each group. The efficacy and safety analysis set included 50 patients in each group.

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, RBP, and Tf at the measurement time was within 10%, respectively. Tolerance interval :The range from the minimum to the maximum values in the OSN-001 group.

The proportion of patients who were out of tolerance interval in Alb, Na, K, Cl, Zn, and Total carnitine was over 10% at a part of time points. Tolerance interval :The range from the minimum to the maximum values in the OSN-001 group.

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%.

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

Dec. 02, 2016

Interventional

Multicenter, randomized, open-label, parallel group trial

treatment purpose

3

(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.

(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

Both

Patients needed enteral nutrition support.

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 : Route, site and frequency of administration should be identical to those details during seven days before enrollment. One day's energy should be identical to the energy per a day by enteral nutrition formula or meals taken during seven days before enrollment.

control material(s)
Generic name etc : OSN-001
INN of investigational material : RACOL-NF Liquid for Enteral Use
Therapeutic category code : 325 Proteins, amino acid and preparations
Dosage and Administration for Investigational material : Route, site and frequency of administration should be identical to those details during seven days before enrollment. One day's energy should be identical to the energy per a day by enteral nutrition formula or meals taken during seven days before enrollment.

efficacy
TTR, RBP, Tf
Student's t-tests and Wilcoxon test will be used between two arms for each parameter at each timepoint and be calculated 95% confidence interval. Number of patients who are within or without tolerance interval (the range from the minimum to the maximum values in the controll group) 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, Total-carnitine, VA, 25OHVD, VE(alpha)
Student's t-tests and Wilcoxon test will be used between two arms for each parameter at each timepoint and be calculated 95% confidence interval. Number of patients who are within or without tolerance interval (the range from the minimum to the maximum values in the controll group) are counted at every timepoint, together with their rate.

Oct. 11, 2016