UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pathologic and therapeutic evaluation of irritable bowel syndrome and ulcerative colitis
Title of the study (Brief title)	Investigation of irritable bowel syndrome and ulcerative colitis
Region	Japan

Condition
Condition	Irritable bowel syndrome and ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To investigate the effectiveness of 5-HT3 receptor antagonistin patients with irritable bowel syndrome or ulcerative colitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Improvement of symptoms
Key secondary outcomes	Compare serotonin or serotonin related gene expression and polymorphisms among the patients with irritable bowel syndrome, ulcerative colitis and sex and age matched controls to identify the predictive factors for the effectiveness of 5-HT3 receptor antagonist

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Treat patient with irritable bowel syndrome using 5ug/day 5HT3 receptor antagonist and ulcerative colitis using 10ug/day for 4weeks
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	Patients with irritable bowel syndrome, ulcerative colitis and sex and age matched controls who plan colonoscopy
Key exclusion criteria	Using SSRI or prokinetics. Patients with constipation, hemorrhagic diseases, insulin-dependent diabetes mellitus, cirrhosis or renal failure.
Target sample size	200

Research contact person
Name of lead principal investigator	Shiotani Akiko
Organization	Kawasaki Medical School
Division name	Gastroentrology
Address	577 Matsushima Kurashiki city 701-0192Japan
TEL	81864621111
Email	shiotani@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Ms. Yamazi
Organization	Kawasaki Medical School
Division name	Research support
Address	577 Matsushima Kurashiki city
TEL	81864621111
Homepage URL
Email	kmsrec@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical School
Institute
Department

Funding Source
Organization	Kawasaki Medical School
Organization
Division
Category of Funding Organization	Self funding
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	2010 Year 08 Month 31 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 11 Month 02 Day
Anticipated trial start date	2015 Year 11 Month 02 Day
Last follow-up date	2016 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 08 Month 30 Day
Last modified on	2017 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000002646