UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004033 |
|---|---|
| Receipt number | R000004850 |
| Scientific Title | Epidemiology and QOL investigation of Chronic Intestinal Pseudoobstruction in Japan |
| Date of disclosure of the study information | 2010/09/01 |
| Last modified on | 2019/02/18 12:09:48 |
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Basic information
Public title
Epidemiology and QOL investigation of Chronic Intestinal Pseudoobstruction in Japan
Acronym
Epidemiology and QOL investigation of Chronic Intestinal Pseudoobstruction in Japan
Scientific Title
Epidemiology and QOL investigation of Chronic Intestinal Pseudoobstruction in Japan
Scientific Title:Acronym
Epidemiology and QOL investigation of Chronic Intestinal Pseudoobstruction in Japan
Region
| Japan |
Condition
Condition
Chronic Intestinal Pseudoobstruction
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Chronic intestinal pseudoobstruction is the syndrome that without intestinal obstructions. CIP is the rare syndrome, and there is no study about prevalence rate of CIP. We study epidemiology and QOL investigation of CIP in Japan.
Basic objectives2
Others
Basic objectives -Others
Chronic intestinal pseudoobstruction is the syndrome that without intestinal obstructions. CIP is the rare syndrome, and there is no study about prevalence rate of CIP. We study epidemiology and QOL investigation of CIP in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-questionnaire about subject of chronic intestinal psudoobstruction.
Self-questionnaire for digestive symptoms.
Key secondary outcomes
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
a. Obtaining informed consent
b. Patient of 15 years or more
c. Patient diagnosed chronic intestinal pseudoobstruction.
Key exclusion criteria
a. Not obtaining informed consent
b. Patient before 15 years
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Nakajima |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2640
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Inamori |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2640
Homepage URL
inamorim@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Gastroenterology Division, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labour and Welfare labor science research expense subsidy
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 01 | 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
| 2010 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
before the observation examination
Management information
Registered date
| 2010 | Year | 08 | Month | 12 | Day |
Last modified on
| 2019 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004850
