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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000011378
Receipt No. R000013317
Scientific Title Cohort observation study about nutrient states on exocrine pancreatic insufficiency patients who administered Pancrelipase Capsules.(Multicentre study)
Date of disclosure of the study information 2013/08/06
Last modified on 2016/02/15

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Basic information
Public title Cohort observation study about nutrient states on exocrine pancreatic insufficiency patients who administered Pancrelipase Capsules.(Multicentre study)
Acronym Cohort observation study on exocrine pancreatic insufficiency patients who administered Pancrelipase Capsules.
Scientific Title Cohort observation study about nutrient states on exocrine pancreatic insufficiency patients who administered Pancrelipase Capsules.(Multicentre study)
Scientific Title:Acronym Cohort observation study on exocrine pancreatic insufficiency patients who administered Pancrelipase Capsules.
Region
Japan

Condition
Condition exocrine pancreatic insufficiency patients
Classification by specialty
Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Prescribe Pancrelipase Capusles to exocrine pancreatic insufficiency patients, gather and assess data on nutrition condition.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Blood exam(albumin,prealbumin,total cholesterol,cholinesterase,hemoglobin etc.),
BMI
Key secondary outcomes prognosis,side effect

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Prescribe Pancrelipase Capusles to exocrine pancreatic insufficiency patients.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria pancreatic insufficiency patients(chronic pancreatitis,pancreas cancer,post pancreas resection,post gastric resetion)
Key exclusion criteria Pasients who are impossible to take capsules orally.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Hirano
Organization Graduate School of Medicine,The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo,Bunkyo-ku,Tokyo 113-8655,Japan
TEL 03-3815-5411
Email khirano-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomotaka Saito
Organization Graduate School of Medicine,The University of Tokyo
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo,Bunkyo-ku,Tokyo 113-8655,Japan
TEL 03-3815-5411
Homepage URL
Email tomsaito623@gmail.com

Sponsor
Institute Department of Gastroenterology, Graduate School of Medicine,The University of Tokyo
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 08 Month 06 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 Suspended
Date of protocol fixation
2012 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 08 Month 05 Day
Last modified on
2016 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013317

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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