UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015859 |
|---|---|
| Receipt number | R000017740 |
| Scientific Title | Analysis of Gastric motility in Functional dyspepsia and Healthy control |
| Date of disclosure of the study information | 2014/12/05 |
| Last modified on | 2017/06/07 09:18:41 |
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Basic information
Public title
Analysis of Gastric motility in Functional dyspepsia and Healthy control
Acronym
Gastric motility in Functional dyspepsia
Scientific Title
Analysis of Gastric motility in Functional dyspepsia and Healthy control
Scientific Title:Acronym
Gastric motility in Functional dyspepsia
Region
| Japan |
Condition
Condition
Healthy volunteer and functional dyspepsia(FD)
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
analysis of gastric motility using HRM
Basic objectives2
Others
Basic objectives -Others
Change of gastric motility by treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of gastric motility in healthy volunteer and FD.
Change of gastric motility in FD after treatment.
Key secondary outcomes
Correlation between gastric motility and symptom
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
acotiamide administration for FD
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
Diagnosis of FD by Rome3 criteria
GOS>=4 in one ofthe questionnaire item
age of >=20
Obtaine IC by document
asymptomatic case is enrolled as healthy control
Key exclusion criteria
Less than 1 year from H.pylori eradication
Took anti-acid medicine within 1 week
Took acotiamide within 4 weeks
drug allergy
severe concomitant disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihito Nagahara |
Organization
Juntendo University School of medicine
Division name
Gastroenterology
Zip code
Address
2-1-1 Hongo Bunkyo-ku Tokyo
TEL
03-3813-3111
nagahara@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihito Nagahara |
Organization
Juntendo University School of medicine
Division name
Gastroenterology
Zip code
Address
2-1-1 Hongo Bunkyo-ku Tokyo
TEL
03-3813-3111
Homepage URL
nagahara@juntendo.ac.jp
Sponsor or person
Institute
Gastroenterology Juntendo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Grants-in-aid for scientific resarch
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2014 | Year | 12 | Month | 05 | 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
| 2014 | Year | 11 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | Month | 21 | 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
| 2014 | Year | 12 | Month | 05 | Day |
Last modified on
| 2017 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017740
