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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023995
Receipt No. 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 2019/03/13

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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
Email 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
Email rei@med.shimane-u.ac.jp

Sponsor
Institute Shimane University Faculty of Medicine
Department of Psychiatry
Institute
Department

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
Email 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 Open public recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 09 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027622

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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