UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001056 |
|---|---|
| Receipt number | R000001267 |
| Scientific Title | Study in Tohoku Preventive Effect of Camostat on Progression of Chronic Pancreatitis |
| Date of disclosure of the study information | 2008/03/01 |
| Last modified on | 2022/11/17 17:13:07 |
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Basic information
Public title
Study in Tohoku Preventive Effect of Camostat on Progression of Chronic Pancreatitis
Acronym
Study in Tohoku Preventive Effect of Camostat on Progression of Chronic Pancreatitis (STOPCP)
Scientific Title
Study in Tohoku Preventive Effect of Camostat on Progression of Chronic Pancreatitis
Scientific Title:Acronym
Study in Tohoku Preventive Effect of Camostat on Progression of Chronic Pancreatitis (STOPCP)
Region
| Japan |
Condition
Condition
chronic pancreatitis
recurrent pancreatitis
alcoholic acute pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Medical treatment for chronic pancreatitis has been intended to ameliorate subjective symptom such as abdominal pain. Oral pancreatic enzymes has been used generally to treat the symptom of chronic pancreatitis. In Japan, oral proteinase inhibitor camostat mesilate (Foipan) has been also used to treat chronic pancreatitis. Here we examine the efficacy of Foipan in preventing the progression of chronic pancreatitis by an open, prospective, multicenter, randomised controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
frequency of pancreatitis attacks
Key secondary outcomes
quality of life
glucose tolerance
pancreatic exocrine function
pancreatic fibrosis
pancreatic inflammation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1 tablet of Foipan to be taken three times a day (300mg/day) after meals for 21 months, following 2 tablets of Foipan three times a day (600mg/day) for 3 months.
Interventions/Control_2
1 gram of Berizym (granules) to be taken three times a day (3 gram /day) after meals for 24 months.
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
Patients who recieved hospital treatment for recurrent pancreatitis or acute exacerbation of chronic pancreatitis.
Outpatients with chronic pancreatitis.
Patients with alcoholic acute pancreatitis.
Key exclusion criteria
1) Patients under 20 years old.
2) Patients with contraindications to Foipan or Berizym.
3) Patients scheduled for surgery, endoscopic treatment, or extracorporeal shock wave lithotripsy(ESWL) as treatment for pancreatitis.
4) Patients whom the attending doctor consider inappropiate to participate in this clinical study for some reason.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tooru |
| Middle name | |
| Last name | Shimosegawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Gastroenterology
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL
022-717-7171
tshimosegawa@int3.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Masamune |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Gastroenterology
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL
022-717-7171
Homepage URL
amasamune@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Division of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
Tel
022-717-7000
med-kenkyo@bureau.tohoku.ac.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
| 2008 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
na
Publication of results
Unpublished
Result
URL related to results and publications
na
Number of participants that the trial has enrolled
100
Results
unpublished
Results date posted
| 2022 | Year | 11 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
recurrent acute pancreatitis
chronic pancreatitis
Participant flow
follow-up for 2 years
Adverse events
none
Outcome measures
abdominal pain
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2008 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2008 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2008 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | 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
| 2008 | Year | 02 | Month | 26 | Day |
Last modified on
| 2022 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001267
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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