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Confirmatory study of EN-P09 in patients with enteral tube feeding.

Confirmatory study of EN-P09 in patients with enteral tube feeding.

108

Background information on the study drug group (FAS) Age (average): 68.2 years old Sex: Male 23, Female 27 Background information on the control drug group (FAS) Age (average): 61.4 years old Sex: Male 25, Female 26

Number of subjects enrolled in the clinical trial: 108 (54 study drug group, 54 control drug group) Number of subjects who were administered with the investigational drug: 108 (54 study drug group, 54 control drug group) Number of subjects who discontinued the trial after administration of the investigational drug: 7 (4 study drug group, 3 control drug group) FAS: 101 (50 study drug group, 51 control drug group) PPS: 99 (50 study drug group, 49 control drug group) SAS: 108 (54 study drug group, 54 control drug group)

The incidence of adverse events: Study drug group 35.2% (19/54), Control drug group 31.5% (17/54) The incidence of adverse drug reactions: Study drug group 11.1% (6/54), Control drug group 11.1% (16/54) The incidence of serious adverse events: Study drug group none, Control drug group 1.9% (1/54) No serious adverse drug reaction occurred in either group.

The primary endpoints (TTR, RBP, Tf) showed a similar distribution in both groups. Among the secondary endpoints, changes in blood concentrations before and after administration of the investigational drug, differences were observed in K, Cl, P, Se, F-T4, total carnitine, 25OHVD, VE fraction (alpha), and F-T4. The levels of K, Cl, P, Se, total carnitine, 25OHVD, and VE fraction (alpha) were higher in the study drug group than in the control group, and the levels of F-T4 were 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 through administration of enteral feeding via a gastrostomy. The safety of the study drug was also confirmed to be comparable to that of the control drug group.

Sept. 25, 2024

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2031210285

Maruyama Michio

Tanashi Hospital

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

eno_kaihatsu@otsuka.jp

Kan Tadahiro

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

Sept. 01, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1. Patients receiving enteral feeding via a gastrostomy into the stomach.
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 20 years old or more.
4. Patients or the legal representative capable of giving informed consent in wrtiting 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 no residual gastric or intestinal function.
4. Patients with ileus.
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 acid 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 esophagus or stomach, except for minimally invasive surgery such as endoscopic submucosal dissection.
10. Patients with a history of resection of intestines within 1 year before obtaining informed consent , except for slight removal like polyp or appendectomy.
11. Patients with difficulties in taking required amount of blood sample for clinical trial.
12. Patients participated in other clinical trials within 24weeks before obtaining informed consent.
13. Patients who are judged by investigator to be excluded.

Both

Patients with enteral tube feeding

Either EN-P09 or control drug is given to patients through a gastrostomy to perform nutritional management for eleven consecutive days.

Tansthyretin, Retinol-binding protein, Transferrin.

+81-263-58-4567

July. 08, 2021

none