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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210285

Enrollment

110

Registered

2021-08-27

Start date

2021-09-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with enteral tube feeding

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Tansthyretin, Retinol-binding protein, Transferrin.	—

Contacts

Public ContactTadahiro Kan

EN Otsuka Pharmaceutical Co., Ltd.

eno_kaihatsu@otsuka.jp+81-3-6632-3516

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026