UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of lubiprostone on gastric emptying in healthy volunteer
Title of the study (Brief title)	Impact of lubiprostone on gastric emptying in healthy volunteer
Region	Japan

Condition
Condition	gastric emptying
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the impact of lubiprostone on gastric emptying in healthy volunteers.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of gastric emptying parameters after administration of lubiprostone
Key secondary outcomes	Gastrointestinal symptom

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	single dose of lubiprostone 24 microgram 1 tablet
Interventions/Control_2	single dose of lubiprostone 24 microgram 1 tablet and domperidone 10 mirigram 1 tablet
Interventions/Control_3	no medication
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	50 years-old >=
Gender	Male
Key inclusion criteria	who has neither gastrointestinal symptoms, medications taken regularly, nor past history of abdominal surgery.
Key exclusion criteria	who does not match the above condition.
Target sample size	10

Research contact person
Name of lead principal investigator	Takatsugu Yamamoto
Organization	Teikyo University
Division name	Internal Medicine
Address	2-11-1, Kaga, Itabashi-ku, Tokyo
TEL	03-3964-1211
Email	ymmt@med.teikyo-u.ac.jp

Public contact
Name of contact person	Takatsugu Yamamoto
Organization	Teikyo University
Division name	Internal Medicine
Address	2-11-1, Kaga, Itabashi-ku, Tokyo
TEL	03-3964-1211
Homepage URL
Email	ymmt@med.teikyo-u.ac.jp

Sponsor
Institute	Teikyo University
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 12 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 05 Month 04 Day
Last modified on	2018 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025574