UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011378 |
|---|---|
| Receipt number | 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 | 2022/12/25 10:00:30 |
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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
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
tomsaito623@gmail.com
Sponsor or person
Institute
Department of Gastroenterology, Graduate School of Medicine,The University of Tokyo
Institute
Department
Personal name
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
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
Main results already published
Date of protocol fixation
| 2012 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 01 | Day |
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
| 2022 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013317
