UMIN-CTR Clinical Trial

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
Email	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
Email	amasamune@med.tohoku.ac.jp

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	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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001267