臨床研究等提出・公開システム

Date of registration	Nov. 19, 2009
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080220919

Scientific Title	Confirmatory study of P0201 in patients with percutaneous endoscopic gastrostomy feeding.
Public Title

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	EN Otsuka Pharmaceutical Co., Ltd.
	Address	en-kaihatsu@enotsuka.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size
Study Type		Interventional
Study Design	Study Design
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	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
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Patients with percutaneous endoscopic gastrostomy feeding or scheduled to undergo percutaneous endoscopic gastrostomy.
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.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	EN Otsuka Pharmaceutical Co.,Ltd.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-090951
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Jan. 27, 2011	Detail	Changes
5	Jan. 27, 2011	Detail	Changes
4	Oct. 04, 2010	Detail	Changes
3	Oct. 04, 2010	Detail	Changes
2	Mar. 29, 2010	Detail	Changes
1	Nov. 19, 2009	Detail

List of change history