臨床研究等提出・公開システム

A multicenter, randomized, open-label, parallel-group study of EN-P11 in patients with enteral tube feeding.

A multicenter, randomized, open-label, parallel-group study of EN-P11 in patients with enteral tube feeding.

110

Background information on the study drug group (FAS) Age (average): 59.6 years old Sex: Male 20, Female 31 Background information on the control drug group (FAS) Age (average): 65.5 years old Sex: Male 24, Female 27

Number of subjects enrolled in the clinical trial: 110 (54 study drug group, 56 control drug group) Number of subjects who were administered with the investigational drug: 110 (54 study drug group, 56 control drug group) Number of subjects who discontinued the trial after administration of the investigational drug: 8 (3 study drug group, 5 control drug group) FAS: 102 (51 study drug group, 51 control drug group) PPS: 102 (51 study drug group, 51 control drug group) SAS: 110 (54 study drug group, 56 control drug group)

The incidence of adverse events: Study drug group 31.5% (17/54), Control drug group 25.0% (14/56) The incidence of adverse drug reactions: Study drug group 7.4% (4/54), Control drug group 5.4% (3/56) The incidence of serious adverse events: Study drug group 1.9% (1/54), Control drug group 3.6% (2/56) No serious adverse drug reaction occurred in either group.

The primary endpoints (TTR, RBP, Tf) showed similar distributions in both groups. Among the secondary endpoints, statistically significant between-group differences were observed in the changes in blood concentrations from pre- to post-investigational drug administration for Na, Cl, P, Se, total carnitine, 25OHVD, VE fraction (alpha), and T4. The levels of Na, Cl, P, Se, total carnitine, 25OHVD, and VE fraction (alpha) were higher in the study drug group than in the control group, and the level of T4 was lower in the study drug group than in the control group.

The study drug was confirmed to enable the same nutritional management as the control drug for patients who required nutritional management with enteral nutrition. The safety of the study drug was also confirmed to be comparable to that of the control drug.

Sept. 17, 2026

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2021230013

Michio Maruyama

Tanashi Hospital

3-6-1, Midoricho, Nishitokyo Shi, Tokyo

eno_kaihatsu@otsuka.jp

Tadahiro Kan

EN Otsuka Pharmaceutical Co., Ltd.

Nikko Kanda Bldg. 6F, 1-1 Kanda-Ogawamachi, Chiyoda-ku, Tokyo

+81-3-6632-3516

eno_kaihatsu@otsuka.jp

Complete

June. 27, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1. Receiving enteral feeding via enteral tube.
2. Patients being hospitalized.
3. Aged 18 years or older at the time of obtaining informed consent.
4.Written informed consent of free will has been obtained.

1. History of hypersensitivity to any ingredients of study drugs.
2. History of allergy to milk protein.
3. Pateints with Ileus.
4. No residual intestinal function.
5. Severe liver or renal dysfunction (example: acute or chronic renal failure, or cirrhosis).
6. Abnormalities in carbohydrate metabolism including severe diabetes mellitus.
7. Congenital abnormalities in amino acid metabolism.
8. Severe heart disease (example: myocardial infarction), severe hematological disorder (example: aplastic anemia), inflammatory bowel disease, pneumonia, serious diarrhea (example: frequent watery diarrhea), and malignant tumor.
9. Pregnant or wish to become pregnant.
10. History of resection of gastrointestinal tract (esophagus, stomach or intestines) within 1year before obtaining informed consent , except for slight removal like polyp or appendectomy.
11. Taking a diet (regular diet, swallowing control diet, blender diet or paste diet).
12. Difficult to take required amount of blood sample for clinical trial.
13. Participated in clinical trial or the use of unapproved drugs within 24weeks before obtaining informed consent.
14. History of surgery within 4weeks before registration (in case of gastrostomy, minor surgery such as debridement for pressure ulcers, within 2weeks before registration).
15. History of fasting for 3or more consecutive days within 4weeks before registration.
16. Screening test 1
1) Serum AST :100 U/L or more
2) Serum ALT :113 U/L or more
3) Serum Cre :2 mg/dL or more
4) Blood HbA1c :8.0% or more
5) Blood WBC :over 9000/uL
6) Serum CRP :3.0 mg/dL or higher
7) Urinary HCG :positive (not required if menopause has been confirmed, there is no possibility of pregnancy due to surgical procedures in the past, or if it can be confirmed that there has been no sexual activity for more than 1year)
17. Screening test 2
Body temperature :37.5 degrees Celsius or higher (on registration day).
18. Judged by investigator to be excluded.

Both

Patients with enteral tube feeding.

Either EN-P11 or control drug is given to patients through enteral tube to perform nutritional management for eleven consecutive days.

transthyretin, retinol-binding protein, transferrin

+81-243-23-1231

June. 23, 2023

none