UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047847 |
|---|---|
| Receipt number | R000054549 |
| Scientific Title | Investigation of laxative response related factors |
| Date of disclosure of the study information | 2022/05/24 |
| Last modified on | 2025/11/25 13:12:00 |
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Basic information
Public title
Investigation of laxative response related factors
Acronym
Investigation of laxative response related factors
Scientific Title
Investigation of laxative response related factors
Scientific Title:Acronym
Investigation of laxative response related factors
Region
| Japan |
Condition
Condition
chronic constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate laxative response related factors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment response rates and safety between 2 and 6 weeks after starting laxative
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
Patients with chronic constipation
Key exclusion criteria
Patients with constipation due to some organic disorders
Patients who are taking antibiotics
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Mikinori |
| Middle name | |
| Last name | Kataoka |
Organization
International University of Health and Welfare Mita Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
108-8329
Address
1-4-3, Mita, Minato-ku, Tokyo
TEL
03-3451-8121
tmasaoka@mbr.nifty.com
Public contact
Name of contact person
| 1st name | Mikinori |
| Middle name | |
| Last name | Kataoka |
Organization
International University of Health and Welfare Mita Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
108-8329
Address
1-4-3, Mita, Minato-ku, Tokyo
TEL
03-3451-8121
Homepage URL
tmasaoka@mbr.nifty.com
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
International University of Health and Welfare Mita Hospital Ethics Committee
Address
1-4-3, Mita, Minato-ku, Tokyo
Tel
03-3451-8123
rinri-mita@iuhw.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 | 05 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
27
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigate laxative response related factors
Management information
Registered date
| 2022 | Year | 05 | Month | 24 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054549
