Confirmatory study of P0201 in patients with percutaneous endoscopic gastrostomy feeding.
Phase 3
- Conditions
- Patients with percutaneous endoscopic gastrostomy feeding or scheduled to undergo percutaneous endoscopic gastrostomy.
- Registration Number
- JPRN-jRCT2080220919
- Lead Sponsor
- EN Otsuka Pharmaceutical Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
(1)Patients needed enteral nutrition support.
(2)Patients with percutaneous endoscopic gastrostomy feeding or scheduled to undergo percutaneous endoscopic gastrostomy.
(3) 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.
(4)Patients aged 20years old or more.
(5)Patients or the legal representative capable of giving informed consent to participate in the study of their own free will.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method