UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046092 |
|---|---|
| Receipt number | R000052613 |
| Scientific Title | Usefulness of polyethylene glycol for pediatric chronic constipation |
| Date of disclosure of the study information | 2021/11/17 |
| Last modified on | 2024/05/22 09:57:28 |
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Basic information
Public title
Usefulness of polyethylene glycol for pediatric chronic constipation
Acronym
Usefulness of polyethylene glycol for pediatric chronic constipation
Scientific Title
Usefulness of polyethylene glycol for pediatric chronic constipation
Scientific Title:Acronym
Usefulness of polyethylene glycol for pediatric chronic constipation
Region
| Japan |
Condition
Condition
constipation
Classification by specialty
| Gastroenterology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of Mobicol in clinical practice for pediatric chronic constipation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change only magnesium oxide preparation to Mobicol compounded content The number of spontaneous defecations and the amount of change in stool properties in the second week
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Replace magnesium oxide with Mobicol-blended internal medicine
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
| 2 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have been taking magnesium oxide or magnesium oxide in combination with sodium picosulfate due to chronic constipation for more than 2 months before consent is obtained.
Key exclusion criteria
N/A
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toshihiko |
| Middle name | |
| Last name | Kakiuchi |
Organization
Saga University Hospital
Division name
Pediatrics
Zip code
849-8501
Address
5-1-1, Nabeshima, Saga
TEL
0952-34-2314
kakiucht@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshihiko |
| Middle name | |
| Last name | Kakiuchi |
Organization
Saga University Hospital
Division name
Pediatrics
Zip code
849-8501
Address
5-1-1, Nabeshima
TEL
0952-34-2314
Homepage URL
kakiucht@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Saga University Hospital Research cwnter
Address
5-1-1, nabeshima
Tel
0952-34-3400
kenkyu-shinsei@ml.cc.saga-u.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
| 2021 | Year | 11 | Month | 17 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 17 | Day |
Last modified on
| 2024 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052613
