UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010884 |
|---|---|
| Receipt number | R000012739 |
| Scientific Title | Analysis of the association between irritable bowel syndrome and diverticular disease |
| Date of disclosure of the study information | 2013/06/05 |
| Last modified on | 2015/02/08 00:37:19 |
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Basic information
Public title
Analysis of the association between irritable bowel syndrome and diverticular disease
Acronym
Irritable bowel syndrome and diverticular disease
Scientific Title
Analysis of the association between irritable bowel syndrome and diverticular disease
Scientific Title:Acronym
Irritable bowel syndrome and diverticular disease
Region
| Japan |
Condition
Condition
Irritable bowel syndrome, Diverticular disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of colon diverticulosis on irritable bowel syndrome
Basic objectives2
Others
Basic objectives -Others
n/a
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment ofimpact of colon diverticulosis on irritable bowel syndrome
Key secondary outcomes
Assessment of abdominal symptom caused by colonic diverticulosis
Assessment of impact of Calcium antagonists on abdominal symptom
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Consecutive patients undergoing colonoscopy
Key exclusion criteria
Active intra-abdominal and pelvic malignancy
Ulcerative colitis
Crohns disease
microscopic colitis
History of colonic surgical resection
Active GI disorder judged as inappropriate for the trial
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Nakajima |
Organization
Yokohama City University School of Medicine
Division name
Division of Gastroenterology
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama
TEL
0457872640
eiji@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Nakajima |
Organization
Yokohama City University School of Medicine
Division name
Division of Gastroenterology
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama
TEL
0457872640
Homepage URL
eiji@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
n/a
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
横浜市立大学医学部附属病院(神奈川県)
東京都立広尾病院(東京都)
町田市民病院(東京都)
横須賀市民病院(神奈川県)
国際医療福祉大学熱海病院(静岡県)
NTT関東東病院(東京都)
横浜南共済病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.nature.com/ajg/journal/v109/n12/full/ajg2014323a.html
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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
n/a
Management information
Registered date
| 2013 | Year | 06 | Month | 05 | Day |
Last modified on
| 2015 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012739
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
