UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049935 |
|---|---|
| Receipt number | R000056874 |
| Scientific Title | Prospective cohort study of chronic constipation practice |
| Date of disclosure of the study information | 2022/12/28 |
| Last modified on | 2022/12/28 13:09:39 |
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Basic information
Public title
Prospective cohort study of chronic constipation practice
Acronym
Prospective cohort study of chronic constipation practice
Scientific Title
Prospective cohort study of chronic constipation practice
Scientific Title:Acronym
Prospective cohort study of chronic constipation practice
Region
| Japan |
Condition
Condition
constipated person
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyse the therapeutic effect and background factors of the treatment of constipation in patients with constipation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy and safety after starting or changing constipation medication
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. constipation
2. patients with constipation symptoms defined in the Chronic Constipation Guideline as "the inability to expel faeces comfortably and in sufficient quantity". 3. outpatients attending Keio University Hospital and National Hospital Organization Kurihama Medical Centre.
3. outpatients attending Keio University Hospital or National Hospital Organisation Kurihama Medical Centre. 4. patients over 18 years of age at the time of consent.
4. patients who are 18 years of age or older at the time the consent form is obtained. 5. patients whose consent for this study has been obtained.
5. patients whose consent for this study has been obtained.
Key exclusion criteria
1. patients with organic disease as a possible cause of constipation symptoms.
2. other patients who are deemed inappropriate for inclusion in the study by the physician in charge or others.
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Kanai |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
16008582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
takagast@keio.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Mori |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
0333531211
Homepage URL
mori-d@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
0333531211
med-rinri-jimu@adst.keio.ac.jp
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
| 2022 | Year | 12 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 28 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
During the study period, subjects will visit the hospital as described in section 6 Research methods, and necessary observations will be carried out at each prescribed visit. The following information will be collected during observations and examinations.
Management information
Registered date
| 2022 | Year | 12 | Month | 28 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056874
| Research Plan | |
|---|---|
| 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 |
