UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028211
Receipt No. R000032263
Scientific Title Comparison of the Rome IV and Rome III criteria for irritable bowel syndrome with constipation (IBS-C) diagnosis in Japanese
Date of disclosure of the study information 2017/07/14
Last modified on 2018/06/07

* 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 Comparison of the Rome IV and Rome III criteria for irritable bowel syndrome with constipation (IBS-C) diagnosis in Japanese
Acronym Comparison of the Rome IV and Rome III criteria for IBS-C diagnosis in Japanese
Scientific Title Comparison of the Rome IV and Rome III criteria for irritable bowel syndrome with constipation (IBS-C) diagnosis in Japanese
Scientific Title:Acronym Comparison of the Rome IV and Rome III criteria for IBS-C diagnosis in Japanese
Region
Japan

Condition
Condition Irritable Bowel Syndrome
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aims of this study to clarify the proportion of IBS-C using the Rome III and Rome IV criteria among Japanese primary constipation patient using a web questionnaire.
Basic objectives2 Others
Basic objectives -Others The aims of this study to examine the difference of the diagnosis rate of IBS-C using the Rome III and Rome IV criteria among Japanese.
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The proportion of IBS-C using the Rome III and Rome IV criteria among primary constipation patients
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Able to reply to a web questionnaire.
Willing to participate in this study.
Key exclusion criteria Unble to reply to a web questionnaire.
Unwilling to participate in this study.
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasushi Fukushima
Organization Fukuwa Clinic
Division name Internal medicine
Zip code
Address 3-3-11, Nihombashi, Chuo-ku, Tokyo, 103-0027, Japan
TEL 03-6262-3751
Email yasushi.fukushima.fw@toc-fukuwa.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Fukushima
Organization Fukuwa Clinic
Division name Internal medicine
Zip code
Address 3-3-11, Nihombashi, Chuo-ku, Tokyo, 103-0027, Japan
TEL 03-6262-3751
Homepage URL
Email yasushi.fukushima.fw@toc-fukuwa.jp

Sponsor
Institute Fukuwa Clinic
Institute
Department

Funding Source
Organization None
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 医療法人社団福和会 福和クリニック(東京都)/ Fukuwa Clinic(Tokyo)

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 14 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
2017 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 04 Day
Last follow-up date
2017 Year 08 Month 31 Day
Date of closure to data entry
2017 Year 09 Month 15 Day
Date trial data considered complete
2017 Year 09 Month 30 Day
Date analysis concluded
2017 Year 11 Month 30 Day

Other
Other related information The exclusive web questionnaire is used for this study.

Management information
Registered date
2017 Year 07 Month 13 Day
Last modified on
2018 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032263

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.