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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024032
Receipt No. R000027678
Scientific Title The effect of mosapride on upper esophageal sphincter in healthy subjects
Date of disclosure of the study information 2016/09/14
Last modified on 2018/03/27

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Basic information
Public title The effect of mosapride on upper esophageal sphincter in healthy subjects
Acronym Effect of mosapride on UES
Scientific Title The effect of mosapride on upper esophageal sphincter in healthy subjects
Scientific Title:Acronym Effect of mosapride on UES
Region
Japan

Condition
Condition disorder of esophageal motility
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the upper esophageal sphincter function after administration of mosapride.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes resting upper esophageal sphincter pressure
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 administration of mosapride
Interventions/Control_2
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
70 years-old >
Gender Male and Female
Key inclusion criteria healthy adults, and subjects with written informed consent
Key exclusion criteria 1.subjects with a history of allegy for drugs
2.subjects with a history of allegy for anesthetic drug
3.subjects with a history of gastrectomy and/or vagotomy
4.subjects undergoing treatment with some disease
5.Other who are not eligible for participation judged by a doctor
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Kinoshita
Organization Shimane University Faculty of Medicine
Division name Second Department of Internal Medicine
Zip code
Address 89-1 Enya-cho,Izumo,Shimane 693-8501
TEL 0853-20-2190
Email d_h_m202@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironobu Mikami
Organization Shimane University Faculty of Medicine
Division name Second Department of Internal Medicine
Zip code
Address 89-1 Enya-cho,Izumo,Shimane 693-850
TEL 0853-20-2190
Homepage URL
Email d_h_m202@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine, Second Department of Internal Medicine
Institute
Department

Funding Source
Organization Shimane University Faculty of Medicine, Second Department of Internal Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 09 Month 14 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
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 13 Day
Last modified on
2018 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027678

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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