UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022441 |
|---|---|
| Receipt number | R000025863 |
| Scientific Title | Effect of acotiamide to prevent the dyspepsia after gastrectomy |
| Date of disclosure of the study information | 2018/10/31 |
| Last modified on | 2018/10/20 15:15:40 |
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Basic information
Public title
Effect of acotiamide to prevent the dyspepsia after gastrectomy
Acronym
Acotiamide to preventthe dyspepsia after gastrectomy
Scientific Title
Effect of acotiamide to prevent the dyspepsia after gastrectomy
Scientific Title:Acronym
Acotiamide to preventthe dyspepsia after gastrectomy
Region
| Japan |
Condition
Condition
Patients after gastrectomy
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prevent the dyspepsia after gastrectomy and reduce gastrectomy-related sarcopenia
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Rome III Diagnostic Criteria(4,8w)
Key secondary outcomes
Food intakes
CT findings
Nutrition
SF-NDI
F-sacle
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
acotiamide 300mg/ day per 4 weeks
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Age:from 20 to 84
gender: both
inpatient and outpatient
patinets after gastorectomy and oral intake is started until 7 post-operative days
Key exclusion criteria
Unresectable gastric cancer
jejunostomy
total gastorectomy
Allergenic history
Pregnancy
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Eguchi |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Surgery
Zip code
Address
sakamoto 1-7-1
TEL
095-819-7316
sueguchi@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kobayashi Shinichiro |
Organization
Nagasaki University Graduate School of Biomedical Sciences
Division name
Surgery
Zip code
Address
sakamoto 1-7-1
TEL
095-819-7316
Homepage URL
shinichirokobayashi@nagasaki-u.ac.jp
Sponsor or person
Institute
Department of surgery, Nagasaki University Graduate School of Biomedical Sciences
Institute
Department
Personal name
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)
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 | 10 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 13 | 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 | 05 | Month | 24 | Day |
Last modified on
| 2018 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025863
