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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001056
Receipt No. 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 2011/11/10

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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
Middle name
Last name Tooru Shimosegawa
Organization Tohoku University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL 022-717-7171
Email

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Masamune
Organization Tohoku University Graduate School of Medicine
Division name Division of Gastroenterology
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL 022-717-7171
Homepage URL
Email

Sponsor
Institute Tohoku University Graduate School of Medicine
Division of Gastroenterology
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2008 Year 03 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 Open public recruiting
Date of protocol fixation
2008 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
2016 Year 03 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
2011 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001267

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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