UMIN-CTR 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 | 2025/05/19 18:21:27 |
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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
https://www.jstage.jst.go.jp/article/jjsps/61/2/61_147/_pdf/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jjsps/61/2/61_147/_pdf/-char/ja
Number of participants that the trial has enrolled
98
Results
In the 98 subjects included in the study, Mobicol significantly increased the frequency of defecation from 1.16 +- 0.98 times/week before treatment to 5.36 +- 4.68 times/week after 4 weeks, and this effect was sustained for more than 60 weeks. Improvement in the fecal shape was also observed. The number of enemas also decreased significantly with the effect. No serious adverse events were observed, and no adverse effects were observed over a mean treatment period of more than 2 years.
Results date posted
| 2025 | Year | 05 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 04 | Month | 20 | Day |
Baseline Characteristics
Of the 98 eligible patients, the male/female ratio was 43:55, the mean age was 4.3 years, median 3.0 years, and the frequency of defecation was 1.16 +- 0.98 times per week. In terms of stool shape, of the 53 patients excluding unknown, 31 had hard stools with BSFS 1 and 2, 19 had normal stools with BSFS 3, 4 and 5, and 3 had soft stools with BSFS 6 and 7. There were 60 patients with previous treatment, of which osmotic laxatives were used in 46 patients, herbal medicines in 21 patients and stimulant laxatives in 13 patients (duplicates). Of the 30 patients in which enemas or suppositories were used, 26 were enema-using patients. Nine patients had anal fissures and 7 patients had defecation pain.
Participant flow
Of the 21 patients of discontinuation within the study period in 98 eligible patients, 2 were at the request of the patient, 1 moved away, 3 interrupted visits, 13 were loss to follow-up, 1 had insufficient efficacy and 1 was unknown.
Adverse events
Adverse events were observed in 12 out of 98 patients and 16 cases, but no serious event was observed and no causal relationship with Mobicol was confirmed.
Outcome measures
<Primary outcomes>
The number of defecations significantly increased from 1.16 +- 0.98 per week before Mobicol treatment to 5.36 +- 4.68 per week after 4 weeks (P<0.001).
<Secondary outcomes>
The number of defecations increased significantly from 1.16 +- 0.98 per week before the start of Mobicol treatment to 5.63 +- 4.81 at 12 weeks, 5.21 +- 4.47 at 24 weeks and 5.23 +- 6.81 at 60 weeks, with significant increases at all time points until the end of treatment. The Mobicol dose remained 8.14 +- 2.6 packets/week at the start, 8.74 +- 3.37 packets/week after 4 weeks of treatment, 9.33 +- 4.64 packets/week after 60 weeks and 9.15 +- 4.58 packets/week at the end of treatment.
The proportion of patients for the stool shape was 58.5% with hard stools, 35.8% with normal stools and 5.7% with soft stools before the start of Mobicol treatment, but after 4 weeks of treatment, the proportion of patients with normal stools increased to 68.6%, and after 24 weeks, more than 80% of patients with normal stools showed improvement, which was sustained until 60 weeks after treatment.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 10 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 11 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 13 | Day |
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 06 | Month | 19 | Day |
Last modified on
| 2025 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058592
