UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037335 |
|---|---|
| Receipt number | R000042561 |
| Scientific Title | Efficacy and safety of Movicol in combination with or after switching from the existing therapy in patients with chronic constipation (Retrospective observation research) |
| Date of disclosure of the study information | 2019/07/11 |
| Last modified on | 2019/12/23 17:10:13 |
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Basic information
Public title
Efficacy and safety of Movicol in combination with or after switching from the existing therapy in patients with chronic constipation(Retrospective observation research)
Acronym
Efficacy and safety of Movicol in combination with or after switching from the existing therapy in patients with chronic constipation(Retrospective observation research)
Scientific Title
Efficacy and safety of Movicol in combination with or after switching from the existing therapy in patients with chronic constipation (Retrospective observation research)
Scientific Title:Acronym
Efficacy and safety of Movicol in combination with or after switching from the existing therapy in patients with chronic constipation (Retrospective observation research)
Region
| Japan |
Condition
Condition
Chronic constipation
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine efficacy and safety of Movicol in combination with or after switching from the existing therapy (magnesium oxide, etc.) in patients with chronic constipation with inadequate response to the existing therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of CSS total score between baseline and at Week 4 of administration
Key secondary outcomes
JPAC-QOL score
CSS total score (of each evaluation time point from baseline to Week 8)
CSS sub score (at each evaluation time point from baseline to Week 8)
Bristol Stool Form Scale
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with chronic constipation and assessed as inadequate responders to the existing therapy (magnesium oxide, etc.)
2) Patients with 20 years or older at baseline
3) Patients receiving Movicol during the investigation period
4) Patients receiving the existing therapy (magnesium oxide, etc.) from more than 2 weeks before administration of Movicol
Key exclusion criteria
1) Patients who are suspected constipation due to organic disease
2) Patients with a history of hypersensitivity to any ingredients of Movicol
3) Patients who are confirmed or suspected intestinal obstruction, intestinal perforation, or severe inflammatory bowel disease (ulcerative colitis, Crohn's disease, toxic megacolon, etc.)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Maeda |
Organization
TSUJINAKA HOSPITAL KASHIWANOHA
Division name
Coloprocrology
Zip code
277-0871
Address
148 Block 6 of the Kashiwanoha Campus,178-2,Wakashiba, Kashiwa, Chiba
TEL
04-7137-3737
takafumisachiyo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takafumi |
| Middle name | |
| Last name | Maeda |
Organization
TSUJINAKA HOSPITAL KASHIWANOHA
Division name
Coloprocrology
Zip code
277-0871
Address
148 Block 6 of the Kashiwanoha Campus,178-2,Wakashiba, Kashiwa, Chiba
TEL
04-7137-3737
Homepage URL
takafumisachiyo@yahoo.co.jp
Sponsor or person
Institute
TSUJINAKA HOSPITAL KASHIWANOHA
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
Joint Ethical Review Board
Address
1-14, Minamikubo, Kochi City, Kochi Prefecture
Tel
042-648-5551
godou-irb@epsogo.co.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
医療法人社団康喜会 辻仲病院柏の葉
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 11 | 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
67
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
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 20 | Day |
Other
Other related information
Comparison of the total constipation scoring system (CSS) score at baseline and Week 4
Management information
Registered date
| 2019 | Year | 07 | Month | 11 | Day |
Last modified on
| 2019 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042561
