UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of Ramosetron on Irritable Bowel Syndrome - like Symptoms in Patients with Inactive Inflammatory Bowel Disease - A Randomized, Double-blind, Placebo-Controlled Study -
Acronym	Efficacy of Ramosetron on Irritable Bowel Syndrome - like Symptoms in Patients with Inactive Inflammatory Bowel Disease
Scientific Title	Efficacy of Ramosetron on Irritable Bowel Syndrome - like Symptoms in Patients with Inactive Inflammatory Bowel Disease - A Randomized, Double-blind, Placebo-Controlled Study -
Scientific Title:Acronym	Efficacy of Ramosetron on Irritable Bowel Syndrome - like Symptoms in Patients with Inactive Inflammatory Bowel Disease
Region	Japan

Condition
Condition	Inactive Inflammatory bowel disease with Irritable bowel syndrome-like symptoms diadnosed by Rome III criteria
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy with the use of ramosetron on Irritable bowel syndrome-like symptoms in patients with Inactive Inflammatory bowel disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Monthly responder rates of global assessment of relief of overall IBS symptoms,
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Ramosetron
Interventions/Control_2	Placebo
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1)Inactive IBD patients with diarrhea predominant IBS-like symptom diagnosed according to the Rome III criteria. 2)The remission stage of IBD was defined as follows. CD: Crohn's disease activity Index index under 150, UC: clinical activity index for the evaluation of patients with ulcerative colitis index under 4 and CRP under 0.3. 3)They had type 6 or 7 stool form, as scored by BSFS, recorded during the baseline period; had bowel movements 2 days or more per week. 4)Organic diseases were excluded by total colonoscopy or double-contrast barium enema.These examinations had to have been performed within 2 years before the provisional registration of subjects and after the onset of IBS symptoms. 5)They recorded all items in the patient diary for 5 days or more during the baseline period.
Key exclusion criteria	Candidates were excluded from participation if they had a history of abdominal surgery, had serious infectious colitis, had a history of ischemic colitis, had ischemic colitis.
Target sample size	70

Research contact person
Last name of lead principal investigator	1st name Hiroto Middle name Last name Miwa
Organization	Hyogo College of Medicine
Division name	Division of Gastroenterology, Department of Internal Medicine
Zip code	663-8501
Address	Nishinomiya
TEL	0798456661
Email	tomita@hyo-med.ac.jp

Public contact
1st name of contact person	1st name Toshihiko Middle name Last name Tomita
Organization	Dr.
Division name	Division of Gastroenterology, Department of Internal Medicine
Zip code	663-8501
Address	Nishinomiya
TEL	0798456661
Homepage URL
Email	tomita@hyo-med.ac.jp

Sponsor
Institute	Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Astellas Pharma Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Hyogo College of Medicine
Address	1-1, Mukogawachou, Nishinomiya, Hyogo
Tel	0798-45-6662
Email	tomita@hyo-med.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 07 Month 30 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	2016 Year 06 Month 29 Day
Date of IRB	2015 Year 11 Month 16 Day
Anticipated trial start date	2016 Year 07 Month 30 Day
Last follow-up date	2019 Year 03 Month 26 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 07 Month 29 Day
Last modified on	2019 Year 03 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026901