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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036569
Receipt No. R000041667
Scientific Title An exploratory study to evaluate the efficacy of novel enteral nutrition VVT-01 for nasal tube feeding patients
Date of disclosure of the study information 2019/04/22
Last modified on 2019/04/22

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Basic information
Public title An exploratory study to evaluate the efficacy of novel enteral nutrition VVT-01 for nasal tube feeding patients
Acronym An exploratory study to evaluate the efficacy of novel enteral nutrition VVT-01
Scientific Title An exploratory study to evaluate the efficacy of novel enteral nutrition VVT-01 for nasal tube feeding patients
Scientific Title:Acronym An exploratory study to evaluate the efficacy of novel enteral nutrition VVT-01
Region
Japan

Condition
Condition nasal tube feeding patients
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To observe the effect of novel enteral nutrition VVT-01 on nutritional condition, fever symptoms, digestive symptoms such as diarrhea, vomiting.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes body weight
Key secondary outcomes Digestive symptoms (diarrhea and vomiting frequency), defecation situation (defecation frequency and fecal condition), fever frequency, nutritional condition (serum albumin)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Administered novel enteral nutrition VVT-01 for 12 weeks
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Subjects who receive transnasal nutrition.
2. Subjects who are 50 years or older.
3. Subjects who have an expectation to continue transnasal nutrition more than 1 month.
Key exclusion criteria 1. Subjects who have serious disease such as liver, kidney, heart, lung, digestive, hematological and metabolic.
2. Subjects who have history of drug or serious food allergy.
3. Subjects who are participate in the other study about drug during the study period.
4. Subjects whose energy doses are not stable for the last 1 month.
5. Subjects judged inappropriate for the study by the investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Takumi
Middle name
Last name Serita
Organization Michinoo hospital
Division name Psychiatry
Zip code 852-8055
Address 1-1, Nijigaoka, Nagasaki, Nagasaki, Japan
TEL 095-856-1111
Email dr-serita@michinoo.or.jp

Public contact
Name of contact person
1st name Takumi
Middle name
Last name Serita
Organization Michinoo hospital
Division name Psychiatry
Zip code 852-8055
Address 1-1, Nijigaoka, Nagasaki, Nagasaki, Japan
TEL 095-856-1111
Homepage URL
Email dr-serita@michinoo.or.jp

Sponsor
Institute Michinoo hospital
Institute
Department

Funding Source
Organization MORINAGA MILK INDUSTRY CO.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Michinoo hospital IRB
Address 1-1, Nijigaoka, Nagasaki, Nagasaki, Japan
Tel 095-856-1111
Email dr-serita@michinoo.or.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 22 Day
Last modified on
2019 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041667

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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