JRCT ID: jRCT2080220919
Registered date:19/11/2009
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Patients with percutaneous endoscopic gastrostomy feeding or scheduled to undergo percutaneous endoscopic gastrostomy. |
Date of first enrollment | 19/11/2009 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : P0201 INN of investigational material : Therapeutic category code : 32- Nutrients, tonics and alteratives Dosage and Administration for Investigational material : The standard dose of P0201 is decided 20-30 kcal/kg per day at time of entry. |
Outcome(s)
Primary Outcome | |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include 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. |
Exclude criteria |
Related Information
Primary Sponsor | EN Otsuka Pharmaceutical Co.,Ltd. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-090951 |
Contact
Public contact | |
Name | |
Address | en-kaihatsu@enotsuka.co.jp |
Telephone | |
Affiliation | EN Otsuka Pharmaceutical Co., Ltd. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |