UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027622