UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004128
Receipt number R000002646
Scientific Title Pathologic and therapeutic evaluation of irritable bowel syndrome and ulcerative colitis
Date of disclosure of the study information 2010/08/31
Last modified on 2017/09/07 16:41:39

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Pathologic and therapeutic evaluation of irritable bowel syndrome and ulcerative colitis

Acronym

Investigation of irritable bowel syndrome and ulcerative colitis

Scientific Title

Pathologic and therapeutic evaluation of irritable bowel syndrome and ulcerative colitis

Scientific Title:Acronym

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

1st name
Middle name
Last name Shiotani Akiko

Organization

Kawasaki Medical School

Division name

Gastroentrology

Zip code


Address

577 Matsushima Kurashiki city 701-0192Japan

TEL

81864621111

Email

shiotani@med.kawasaki-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ms. Yamazi

Organization

Kawasaki Medical School

Division name

Research support

Zip code


Address

577 Matsushima Kurashiki city

TEL

81864621111

Homepage URL


Email

kmsrec@med.kawasaki-m.ac.jp


Sponsor or person

Institute

Kawasaki Medical School

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Partially published


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

Main results already published

Date of protocol fixation

2015 Year 11 Month 02 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002646


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name