UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005347 |
|---|---|
| Receipt number | R000006325 |
| Scientific Title | Randomized control trials for the efficacy of the elemental diet "elental" for the chronic pancreatitis |
| Date of disclosure of the study information | 2011/04/01 |
| Last modified on | 2015/03/30 18:41:37 |
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Basic information
Public title
Randomized control trials for the efficacy of the elemental diet "elental" for the chronic pancreatitis
Acronym
The efficacy of the elemental diet for the chronic pancreatitis
Scientific Title
Randomized control trials for the efficacy of the elemental diet "elental" for the chronic pancreatitis
Scientific Title:Acronym
The efficacy of the elemental diet for the chronic pancreatitis
Region
| Japan |
Condition
Condition
chronic pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the improvement of nutrition by elemental diet "elental" for chronic pancreatitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of nutrition
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
elemental diet "elental" group
Interventions/Control_2
no elemental diet "elental" group
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
chronic pancreatitis patients that were performed endoscopical pancreatic stenting
Key exclusion criteria
1. inability to provide written informed consent
2. performance status of 4
3. past history of drug allergy
4. cases with other severe diseases
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Kawaguchi |
Organization
Tokai University School of Medicine
Division name
Gastroenterology
Zip code
Address
143, Shimokasuya, Isehara
TEL
0463-93-1121
y711kawa@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Kawaguchi |
Organization
Tokai University School of Medicine
Division name
Gastroenterology
Zip code
Address
143 Shimokasuya, Isehara
TEL
0463-93-1121
Homepage URL
y711kawa@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 04 | Month | 01 | 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
| 2011 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 01 | 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
| 2011 | Year | 03 | Month | 30 | Day |
Last modified on
| 2015 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006325
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
