UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028211 |
|---|---|
| Receipt number | 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 13:05:06 |
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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
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
yasushi.fukushima.fw@toc-fukuwa.jp
Sponsor or person
Institute
Fukuwa Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032263
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
