UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009547 |
|---|---|
| Receipt number | R000011185 |
| Scientific Title | Prospectivestudy on the treatment effect of pancrelipase on chronic pancreatitis patient's alubumin concentration |
| Date of disclosure of the study information | 2013/01/01 |
| Last modified on | 2012/12/14 11:04:29 |
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Basic information
Public title
Prospectivestudy on the treatment effect of pancrelipase on chronic pancreatitis patient's alubumin concentration
Acronym
Examination of effect to albumin with pancrelipase in chronic pancreatitis
Scientific Title
Prospectivestudy on the treatment effect of pancrelipase on chronic pancreatitis patient's alubumin concentration
Scientific Title:Acronym
Examination of effect to albumin with pancrelipase in chronic pancreatitis
Region
| Japan |
Condition
Condition
Chronic pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the treatment effect of pancrelipase on the chronic pancreatitis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of albumin
Key secondary outcomes
1)Change of amylase and lipase
2)Improvement of nutrition
3)Improvement of VAS score
4)Improvement of dyspepsia
5)Improvement of stool consistency and count
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
| Medicine |
Interventions/Control_1
600mg of Pancrelipase (granules or capsels) to be taken three times a day (1800mg /day) after meals for 4 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic pancreatitis patients
1)Patient who has intention according to plan
2)Patient who is sign in document
3)Patient suffering from dyspepsia
4)Patient whose BT-PABA test results are 70% or less (Suspected CP or early-stage CP)
Key exclusion criteria
1)Alegyin procion protein or digestive enzym
2)Case with possibility of pregnancy,during nursing
3)Participates in other examinations.
4)Sever infection
5)In addition, the case judged to be inappropriate for the examination to carry out this study safely
Target sample size
83
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Inui |
Organization
Department of Internal Medicine Second Teaching Hospital Fujita Health University School of Medicine
Division name
Gastroenterology
Zip code
Address
3-6-10,Otobashi,Nakagawa-ku,Nagoya
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoji Yamamoto |
Organization
Department of Internal Medicine Second Teaching Hospital Fujita Health University School of Medicine
Division name
Gastroenterology
Zip code
Address
3-6-10,Otobashi,Nakagawa-ku,Nagoya
TEL
Homepage URL
Sponsor or person
Institute
Department of Internal Medicine Second Teaching Hospital Fujita Health University School of Medicine
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
藤田保健衛生大学病院（愛知県）
藤田保健衛生大学第二教育病院（愛知県）
名古屋市立大学病院（愛知県）
三重大学医学部附属病院（三重県）
愛知医科大学病院（愛知県）
岐阜大学医学部附属病院（岐阜県）
ＮＴＴ西日本東海病院（愛知県）
静岡県立総合病院（静岡県）
医療法人光生会病院（愛知県）
岐阜県総合医療センター（岐阜県）
国民健康保険坂下病院（岐阜県）
独法国立病院機構 静岡医療センター（静岡県）
愛知県がんセンター中央病院（愛知県）
名古屋第二赤十字病院（愛知県）
春日井市民病院（愛知県）
朝日大学歯学部附属村上記念病院（岐阜県）
岐阜市民病院 消化器内科（岐阜県）
岐阜県立多治見病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | 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
| 2012 | Year | 12 | Month | 14 | Day |
Last modified on
| 2012 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011185
