UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023399
Receipt number R000026901
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 -
Date of disclosure of the study information 2016/07/30
Last modified on 2019/03/27 09:13:58

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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

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

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 or person

Institute

Hyogo College of Medicine

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026901


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name