UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048883 |
|---|---|
| Receipt number | R000055702 |
| Scientific Title | Effect and Adverse events of polyethylene glycol preparation combination in constipated patients with severe motor and intellectual disability |
| Date of disclosure of the study information | 2022/09/11 |
| Last modified on | 2022/12/20 18:25:57 |
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Basic information
Public title
Effect and Adverse events of polyethylene glycol preparation combination in constipated patients with severe motor and intellectual disability
Acronym
Effect and Adverse events of polyethylene glycol preparation combination in constipated patients with severe motor and intellectual disability
Scientific Title
Effect and Adverse events of polyethylene glycol preparation combination in constipated patients with severe motor and intellectual disability
Scientific Title:Acronym
Effect and Adverse events of polyethylene glycol preparation combination in constipated patients with severe motor and intellectual disability
Region
| Japan |
Condition
Condition
severe motor and intellectual disability
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A prospective observational study was conducted for examining the effect and adverse events of polyethylene glycol preparation for patients with severe motor and intellectual disabilities (SMID) who have intractable chronic constipation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the number of spontaneous defecation
Key secondary outcomes
the number of usage of cure medicines (e.g. glycerin enema),Stool hardness, adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The drug was administered for 4 weeks,The method of administration was to administer the initial dose to 1 packet at a time, oral or enteral administration once a day for 7 days, and the dose was increased with an interval of 7 days or more depending on the symptoms. The maximum daily dose was limited to 3 packets (2 packets at a time is the maximum).
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
| 19 | years-old | <= |
Age-upper limit
| 67 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients over the age of 19 who are hospitalized in severe motor and intellectual disability ward
2)Patients diagnosed with constipation by doctor
3)Patients who are currently prescribed constipation medication but are prescribed cure medicines and use them frequency.
Key exclusion criteria
1)rectal intussuspocion, rectal prolapse, and megacolon inducing constipation
2)mechanical obstruction
3)past history of inflammatory bowel diseases, colorectal cancer, or bowel obstruction
4)physician determined ineligible
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | YASUFUMI |
| Middle name | |
| Last name | TSURUSAKI |
Organization
National Hospital Organization Higashisaga Hospital
Division name
Department of pharmacy
Zip code
849-0101
Address
7324 Harakoga Miyaki city Miyaki-gun , Saga
TEL
0942942048
tsurusaki.yasufumi.jm@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | YASUFUMI |
| Middle name | |
| Last name | TSURUSAKI |
Organization
National Hospital Organization Higashisaga Hospital
Division name
Department of pharmacy
Zip code
8490101
Address
7324 Harakoga Miyaki city Miyaki-gun , Saga
TEL
0942942048
Homepage URL
tsurusaki.yasufumi.jm@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Higashisaga Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Higashisaga Hospital
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
National Hospital Organization Higashisaga Hospital
Address
7324 Harakoga Miyaki city Miyaki-gun , Saga
Tel
0942942048
tsurusaki.yasufumi.jm@mail.hosp.go.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 | 09 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
12
Results
By administration of MOVICOL, the number of spontaneous defecation was significantly increased (p = 0.04), and the number of usage of cure medicines (e.g. glycerin enema) was decreased (p = 0.03). Stool hardness did not differ before and after MOVICOL administration. No significant adverse events were observed.
MOVICOL can be a new treatment option for patients with SMID who do not respond to conventional therapies for constipation.
Results date posted
| 2022 | Year | 12 | Month | 20 | Day |
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
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 08 | Day |
Last modified on
| 2022 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055702
