UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001673 |
|---|---|
| Receipt number | 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 | 2024/08/13 16:02:30 |
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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 | Shin |
| Middle name | |
| Last name | Fukudo |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Behavioral Medicine
Zip code
980-8575
Address
2-1 Seiryo, Aoba, Sendai
TEL
022-717-8214
sfukudo@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Motoyori |
| Middle name | |
| Last name | Kanazawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Behavioral Medicine
Zip code
980-8575
Address
2-1 Seiryo, Aoba, Sendai, Japan
TEL
022-717-7655
Homepage URL
m-kanazawa@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Science and Culture of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Ethics Committee
Address
2-1 Seiryo, Aoba, Sendai, Japan
Tel
022-717-8007
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
| 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
Completed
Date of protocol fixation
| 2008 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2008 | Year | 06 | Month | 10 | Day |
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
| 2024 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002021
