UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032438 |
|---|---|
| Receipt number | R000036989 |
| Scientific Title | Effects of acotiamide on esophageal motility and EGJ distensibility for gastroesophageal reflux disease. |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2018/05/01 07:03:51 |
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Basic information
Public title
Effects of acotiamide on esophageal motility and EGJ distensibility for gastroesophageal reflux disease.
Acronym
effets of acotiamide for GERD
Scientific Title
Effects of acotiamide on esophageal motility and EGJ distensibility for gastroesophageal reflux disease.
Scientific Title:Acronym
effets of acotiamide for GERD
Region
| Japan |
Condition
Condition
GERD
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is examination in esophageal motor function and distensibility of the esophagogastric junction after administration of acotiamide to GERD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in esophageal motor function and distensibility of the esophagogastric junction after administration of acotiamide 300 mg / day for 3 days and after the last dose 2 hours.
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
Acotiamide 300 mg / day for 3 days
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
GERD patients
Key exclusion criteria
Post operation of esophagus
Target sample size
10
Research contact person
Name of lead principal investigator
| 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, Japan
TEL
0853-20-2190
d_h_m202@yahoo.co.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, Japan
TEL
0853-20-2190
Homepage URL
d_h_m202@yahoo.co.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Second Department of Internal Medicine, Shimane University Faculty of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | 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
| 2018 | Year | 05 | Month | 01 | Day |
Last modified on
| 2018 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036989
