UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of the effect of lubiprostone on intestinal permeability in healthy volunteers
Title of the study (Brief title)	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	Hiroki Endo
Organization	Yokohama City University
Division name	Department of Gastroenterology and Hepatology
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL	045-787-2800ext.6600
Email	endo1978@yokohama-cu.ac.jp

Public contact
Name of contact person	Hiroki Endo
Organization	Yokohama City University
Division name	Department of Gastroenterology and Hepatology
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL	045-787-2800ext.6600
Homepage URL
Email	endo1978@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://journals.plos.org/plosone/article/authors?id=10.1371/journal.pone.0175626
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020122