UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051381 |
|---|---|
| Receipt number | R000058592 |
| Scientific Title | Efficacy and Safety of MACROGOL 4000, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride for Chronic Constipation in Children - A Retrospective Observational Study |
| Date of disclosure of the study information | 2023/06/20 |
| Last modified on | 2023/06/23 13:34:52 |
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Basic information
Public title
Efficacy and Safety of MACROGOL 4000, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride for Chronic Constipation in Children - A Retrospective Observational Study
Acronym
Efficacy and Safety of MACROGOL 4000, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride for Chronic Constipation in Children - A Retrospective Observational Study
Scientific Title
Efficacy and Safety of MACROGOL 4000, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride for Chronic Constipation in Children - A Retrospective Observational Study
Scientific Title:Acronym
Efficacy and Safety of MACROGOL 4000, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride for Chronic Constipation in Children - A Retrospective Observational Study
Region
| Japan |
Condition
Condition
Pediatric patients with chronic constipation
Classification by specialty
| Hepato-biliary-pancreatic medicine | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the long-term efficacy and safety of MOVICOL when administered to children with chronic constipation. In addition, the duration of time that constipation improves after initiation of treatment with MOVICOL and the presence or absence of defecation pain in patients with anal fissures and the proportion of such patients will also be investigated.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of defecation frequency before and after 4 weeks of treatment.
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
| 2 | years-old | <= |
Age-upper limit
| 14 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Outpatients between 2 and 14 years of age at the time of initiation of treatment with MOVICOL. (2)Patients diagnosed with chronic constipation with a bowel movement frequency of once every 3 days or less during the week prior to administration of MOVICOL. (3) Patients newly prescribed and treated with MOVICOLfor at least 4 weeks between December 1, 2018 and December 31, 2022 (4)Patients with a record of defecation frequency prior to initiation of MOVICOL and for at least 4 weeks after MOVICOL administration.
Key exclusion criteria
(1)Patients with a history of hypersensitivity to any ingredient of MOVICOL. (2)Patients with confirmed or suspected intestinal obstruction, intestinal perforation, or severe inflammatory bowel disease (ulcerative colitis, Crohn's disease, toxic megacolon disease, etc.) (3)Patients with suspected constipation due to organic disease (4)Patients who participated in clinical trials or interventional studies during the observation period (5)Patients who were outside the approved dosage and administration of MOVICOL.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yoshiko |
| Middle name | |
| Last name | Watanabe |
Organization
Faculty of Medicine, Kyorin University
Division name
Department of Pediatric Surgery
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422475511
nabey@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiko |
| Middle name | |
| Last name | Watanabe |
Organization
Faculty of Medicine, Kyorin University
Division name
Department of Pediatric Surgery
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
TEL
0422475511
Homepage URL
nabey@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Kyorin University
Institute
Department
Personal name
Funding Source
Organization
EA Pharma Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyorin University School of Medicine Ethics Committee
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo
Tel
0422475511
rec@ks.kyorin-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
| 2023 | Year | 06 | Month | 20 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2023 | Year | 06 | Month | 19 | Day |
Last modified on
| 2023 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058592
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| Registered date | File name |
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