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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001673
Receipt No. R000002021
Scientific Title Role of food intolerance and effect of protease inhibitor in patients with irritable bowel syndrome (IBS)
Date of disclosure of the study information 2009/01/30
Last modified on 2013/08/30

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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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