UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042704 |
|---|---|
| Receipt number | R000048738 |
| Scientific Title | An exploratory study of factors related to the efficacy of abortive use of medications for constipation symptoms in hospitalized patients: a prospective observational study |
| Date of disclosure of the study information | 2020/12/09 |
| Last modified on | 2020/12/09 18:14:40 |
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Basic information
Public title
An exploratory study of factors related to the efficacy of abortive use of medications for constipation symptoms in hospitalized patients: a prospective observational study
Acronym
An exploratory study of factors related to the efficacy of abortive use of medications for constipation symptoms in hospitalized patients
Scientific Title
An exploratory study of factors related to the efficacy of abortive use of medications for constipation symptoms in hospitalized patients: a prospective observational study
Scientific Title:Acronym
An exploratory study of factors related to the efficacy of abortive use of medications for constipation symptoms in hospitalized patients
Region
| Japan |
Condition
Condition
functional constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate how much the findings of gastrointestinal echocardiography affect the effectiveness of treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Association of gastrointestinal echocardiographic findings with the presence or absence of reactive stools
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients diagnosed with functional constipation due to ROME III or IV and undergoing treatment, or hospitalized patients diagnosed with functional constipation due to ROME IV
2. Men and women over 20 years of age at the time of registration
3. Planning to use abortive irritant laxatives or enemas for the treatment of constipation
4. Patients who can obtain consent from themselves or their families to participate in this study
Key exclusion criteria
1. Persons with a history of hypersensitivity to irritating laxatives, enemas
2. Other patients who are deemed unsuitable for the subject by the physician's judgment
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Misawa |
Organization
Yokohama City University school of medicine
Division name
Department of gastroenterology and hepatology
Zip code
236-0004
Address
3-9 Fukuura Kanazawa-ku Yokohama City
TEL
045-787-2640
misawa-ykh@umin.ac.jp
Public contact
Name of contact person
| 1st name | Noboru |
| Middle name | |
| Last name | Misawa |
Organization
Yokohama City University school of medicine
Division name
Department of gastroenterology and hepatology
Zip code
236-0004
Address
3-9 Fukuura Kanazawa-ku Yokohama City
TEL
045-787-2640
Homepage URL
misawa-ykh@umin.ac.jp
Sponsor or person
Institute
Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University School of Medicine Department of Gastroenterology and Hepatology
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
Yokohama City University Graduate School of Medicine
Address
Yokohama City University Graduate School of Medicine
Tel
045-370-7627
rinri@yokohama-cu.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
| 2020 | Year | 12 | Month | 09 | 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
| 2019 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 12 | Month | 09 | Day |
Last modified on
| 2020 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048738
| 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 |
