UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025225 |
|---|---|
| Receipt number | R000029016 |
| Scientific Title | Mechanism study of postprandial gastric motility |
| Date of disclosure of the study information | 2016/12/14 |
| Last modified on | 2021/05/05 14:59:22 |
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Basic information
Public title
Mechanism study of postprandial gastric motility
Acronym
Mechanism study of postprandial motility
Scientific Title
Mechanism study of postprandial gastric motility
Scientific Title:Acronym
Mechanism study of postprandial motility
Region
| Japan |
Condition
Condition
Functional dyspepsia, gastroparesis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify control mechanism of postprandial gastric motility.
Basic objectives2
Others
Basic objectives -Others
To establish crucial treatment for postprandial fullness
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Pattern of postprandial gastric motility
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Uppergastrointestinal manometry
pH monitoring
Blood examination
Taking questionnaire
1 day is needed for this study
Examination time will be 5 hours at longest
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 volunteer who does not match any of below exclusion criteria
Key exclusion criteria
pregnant female
past history of upper gastrointestinal or hepatobiliary or pancreatic surgery
Treated with medication for upper-gastriontestinal symptoms longer than 3 months.
Treated with chemotherapy for cancer or narcotic analgesics
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuhiro Masaoka |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
35 Shinanomachi Shinjukuku Tokyo
TEL
03-5363-3790
masaoka@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuhiro Masaoka |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address
35 Shinanomachi Shinjukuku Tokyo
TEL
03-5363-3790
Homepage URL
masaoka@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
| 2016 | Year | 12 | 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 | 12 | Month | 12 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | 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 | 12 | Month | 12 | Day |
Last modified on
| 2021 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029016
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
