UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017342 |
|---|---|
| Receipt number | R000020122 |
| Scientific Title | Verification of the effect of lubiprostone on intestinal permeability in healthy volunteers |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2018/11/01 10:36:44 |
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Basic information
Public title
Verification of the effect of lubiprostone on intestinal permeability in healthy volunteers
Acronym
Verification of the effect of lubiprostone on intestinal permeability in healthy volunteers
Scientific Title
Verification of the effect of lubiprostone on intestinal permeability in healthy volunteers
Scientific Title:Acronym
Verification of the effect of lubiprostone on intestinal permeability in healthy volunteers
Region
| Japan |
Condition
Condition
Healthy Volunteers
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficiency of Lubiprostone in intestinal permeability
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Permeability of the small intestine using the lactulose/mannitol test
Key secondary outcomes
Endotoxin activity in blood, changes in the intestinal flora
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
24mcg of Lubiprostone once daily after lunch for 14 days or 28 days
Interventions/Control_2
No treatment for 14 days or 28 days
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
1)Men at age >=20 years but <60 years when the consent was obtained
2)Persons who were determined to be healthy adults by the investigator/sub-investigator (hereinafter referred to as investigator, etc.) during medical interview at screening
3)Persons from whom the written consent was obtained and who can abide by the compliance rules while participating in this study, receive medical examination and tests prescribed in this protocol, and report symptoms, etc.
Key exclusion criteria
1)Persons who have received NSAIDs within 3 months before obtaining the consent (excluding topical administration of NSAIDs)
2)Persons with history of food or drug allergy (diclofenac sodium, lubiprostone, etc.) or who are suspected of such allergy
3)Persons with current or history of serious cardiovascular/vascular, hematological, respiratory, liver, kidney, gastrointestinal, or neuropsychiatric disease
4)Persons who are taking proton pump inhibitors (PPIs), antibiotics, or intestinal drugs (excluding topical administration of antibiotics)
5)Persons who have participated in other clinical studies and received the study drug, etc. within 1 month prior to the start of this study (calculated from the administration date of the study drug)
6)Persons who were judged by the investigator, etc. to be inappropriate as a subject for this study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Endo |
Organization
Yokohama City University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-787-2800ext.6600
endo1978@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Endo |
Organization
Yokohama City University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
045-787-2800ext.6600
Homepage URL
endo1978@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Abbott Japan Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
横浜市立大学附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article/authors?id=10.1371/journal.pone.0175626
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
| 2015 | Year | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 30 | Day |
Last modified on
| 2018 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020122
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
