UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory Clinical Study of TJ-83 on Anxiety in Patients with Irritable Bowel Syndrome
Title of the study (Brief title)	(Brief Title: SWORD-C)
Region	Japan

Condition
Condition	irritable bowel syndrome (IBS)
Classification by specialty	Psychosomatic Internal Medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the hypothesis that TJ-83 is effective on anxiety in IBS patients.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Phase IV

Assessment
Primary outcomes	State-Trait Anxiety Inventory (STAI) 12 weeks later after the baseline
Key secondary outcomes	IBS-QOL quantitative GI symptoms Insomnia Severity Index (ISI)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	standard treatment
Interventions/Control_2	standard treatment + TJ-83
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Rome IV
Key exclusion criteria	cancer IBD state after big surgery psychiatric disorders
Target sample size	50

Research contact person
Name of lead principal investigator	Shin Fukudo, MD, PhD
Organization	Tohoku University Hospital
Division name	Department of Psychosomatic Medicine
Address	1-1 Seiryo, Aoba, Sendai 980-8574, Japan
TEL	022-717-8214
Email	sfukudo@med.tohoku.ac.jp

Public contact
Name of contact person	Tomotaka Shoji, MD
Organization	Tohoku University Hospital
Division name	Department of Psychosomatic Medicine
Address	1-1 Seiryo, Aoba, Sendai 980-8574, Japan
TEL	022-717-7327
Homepage URL
Email	tshoji@hosp.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	Tsumura
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 03 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 03 Month 03 Day
Last modified on	2018 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036034