UMIN-CTR Clinical Trial

Basic information
Public title	Role of food intolerance and effect of protease inhibitor in patients with irritable bowel syndrome (IBS)
Acronym	Effect of protease inhibitor in patients with irritable bowel syndrome (IBS)
Scientific Title	Role of food intolerance and effect of protease inhibitor in patients with irritable bowel syndrome (IBS)
Scientific Title:Acronym	Effect of protease inhibitor in patients with irritable bowel syndrome (IBS)
Region	Japan

Condition
Condition	Irritable bowel syndrome (IBS)
Classification by specialty	Gastroenterology Psychosomatic Internal Medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the hypothesis that protease inhibitor, camostat mesilate attenuates colonic hypersensitivity and hyperreactive motility and improves symptom severity in patients with IBS
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adequate relief (AR) at the end of the intervention
Key secondary outcomes	Symptom severity at the end of the intervention

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Camostat mesilate 200mg (t.i.d.) will be administrated for 14 days. Rectal barostat measurements will be performed before and the end of the intervention.
Interventions/Control_2	Placebo (t.i.d.) will be administrated for 14 days. Rectal barostat measurements will be performed before and the end of the intervention.
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 met Rome III diagnostic criteria for IBS
Key exclusion criteria	Patients who have severe systemic/ psychological complications, and/or who have histories of any abdominal surgery except appendectomy, and/or who needs to continue any pharmacological treatment during the study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shin Fukudo, MD, PhD
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Behavioral Medicine
Zip code
Address	2-1 Seiryo, Aoba, Sendai 980-8575, Japan
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Motoyori Kanazawa, MD, PhD
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Behavioral Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute	Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research from the Ministry of Education, Science and Culture of Japan
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	2009 Year 01 Month 30 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	No longer recruiting
Date of protocol fixation	2008 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date	2009 Year 02 Month 01 Day
Last follow-up date	2012 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	2009 Year 01 Month 30 Day
Last modified on	2013 Year 08 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002021

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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