UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021344 |
|---|---|
| Receipt number | R000024613 |
| Scientific Title | The effect of acotiamide on esophageal motor activity and esophagogastric junction distensibility |
| Date of disclosure of the study information | 2016/03/07 |
| Last modified on | 2021/03/31 13:31:34 |
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Basic information
Public title
The effect of acotiamide on esophageal motor activity and esophagogastric junction distensibility
Acronym
The effect of acotiamide on esophageal motor activity and esophagogastric junction distensibility
Scientific Title
The effect of acotiamide on esophageal motor activity and esophagogastric junction distensibility
Scientific Title:Acronym
The effect of acotiamide on esophageal motor activity and esophagogastric junction distensibility
Region
| Japan |
Condition
Condition
Gastroesophageal reflux disease(GERD)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of acotiamide on esophageal motor activity and esophagogastric junction distensibility in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
evaluation of esophageal motor activity and esophagogastric distensibility after administration of acotiamide
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
oral administration of acotiamide
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.healthy adults
2.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
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 693-8501
TEL
0853-20-2190
Homepage URL
d_h_m202@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine, Second Department of Internal Medicine
Institute
Department
Personal name
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
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 | 03 | Month | 07 | 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
| 2015 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 04 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024613
