UMIN-CTR Clinical Trial

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
Email	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
Email	takafumisachiyo@yahoo.co.jp

Sponsor
Institute	TSUJINAKA HOSPITAL KASHIWANOHA
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042561