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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Irritable bowel syndrome (IBS) | ||
Classification by specialty |
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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 |
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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 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Organization | Tohoku University Graduate School of Medicine | ||||||
Division name | Department of Behavioral Medicine | ||||||
Zip code | |||||||
Address | 2-1 Seiryo, Aoba, Sendai 980-8575, Japan | ||||||
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Organization | Tohoku University Graduate School of Medicine | ||||||
Division name | Department of Behavioral Medicine | ||||||
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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 | |
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Category of Funding Organization | |
Nationality of Funding Organization | Japan |
Other related organizations | |
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IRB Contact (For public release) | |
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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 |
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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 | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
Date of protocol fixation |
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |