UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023995 |
|---|---|
| Receipt number | R000027622 |
| Scientific Title | Effect of serotonin-norepinephrine reuptake inhibitor on functional gastrointestinal disorder and evaluation of the brain function. |
| Date of disclosure of the study information | 2016/09/09 |
| Last modified on | 2019/09/12 13:21:29 |
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Basic information
Public title
Effect of serotonin-norepinephrine reuptake inhibitor on functional gastrointestinal disorder and evaluation of the brain function.
Acronym
Effect of SNRI on functional gastrointestinal disorder
Scientific Title
Effect of serotonin-norepinephrine reuptake inhibitor on functional gastrointestinal disorder and evaluation of the brain function.
Scientific Title:Acronym
Effect of SNRI on functional gastrointestinal disorder
Region
| Japan |
Condition
Condition
functional gastrointestinal disorder
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effect, safety and influence to brain function of SNRI are evaluated in patients with functional gastrointestinal disorders.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
PAGI-SYM:The change in the general score and the lower rank score of PAGI-SYM between a baseline and 6 weeks later of prescription.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The patients in functionality gastrointestinal disease throw duloxetine 20mg to average treatment for 6 weeks.
Interventions/Control_2
The patients in functionality gastrointestinal disease throw PURASEBO to average treatment for 6 weeks.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Agreement by a document can be acquired from the patient who didn't also admit improvement of the symptom using a curative for the first step which appears on a guideline by functionality dyspepsia or hypersensitive gut syndrome and a checked case from the symptom and an examination in endoscope.
Key exclusion criteria
The case which isn't treated by other anti-depressants.
The case with the medical history of the hyperesthesia.
The case which merges the disease judged to have an influence on the life of the patient.
The case with which I participated in other clinical trials and clinical tests within 6 months before experimental drug prescription.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Rei |
| Middle name | |
| Last name | Wake |
Organization
Shimane University Faculty of Medicine
Division name
Department of Psychiatry
Zip code
6938501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-23-2111
rei@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Rei |
| Middle name | |
| Last name | Wake |
Organization
Shimane University Faculty of Medicine
Division name
Department of Psychiatry
Zip code
6938501
Address
89-1 Enya-cho, Izumo, Shimane
TEL
0853-23-2111
Homepage URL
rei@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Department of Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Shimane University Faculty of Medicine
Department of Psychiatry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University
Address
89-1 Enya-cho, Izumo city, Shimane
Tel
0853202262
rei@med.shimane-u.ac.jp
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 | 09 | Month | 09 | 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 | 11 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 28 | Day |
Date of closure to data entry
| 2018 | Year | 09 | Month | 28 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 28 | Day |
Date analysis concluded
| 2018 | Year | 09 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 09 | Day |
Last modified on
| 2019 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027622
| Research Plan | |
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| 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 |
