UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter prospective study to evaluate the effect of elobixibat on spontaneous defecation without a feeling of residual stool in patients with chronic constipation who are inadequately effective with magnesium oxide, a first-line treatment for constipation.
Acronym	A multicenter prospective study to evaluate the effect of elobixibat on spontaneous defecation without a feeling of residual stool in patients with chronic constipation who are inadequately effective with magnesium oxide, a first-line treatment for constipation.
Scientific Title	A multicenter prospective study to evaluate the effect of elobixibat on spontaneous defecation without a feeling of residual stool in patients with chronic constipation who are inadequately effective with magnesium oxide, a first-line treatment for constipation.
Scientific Title:Acronym	A multicenter prospective study to evaluate the effect of elobixibat on spontaneous defecation without a feeling of residual stool in patients with chronic constipation who are inadequately effective with magnesium oxide, a first-line treatment for constipation.
Region	Japan

Condition
Condition	chronic constipation
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficacy of elobixibat for patients with chronic constipation who are refractory to magnesium oxide
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Difference in spontaneous bowel movements (SBM) before and after switching to study drug
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Orally administer 10 mg of elobixibat once daily before meals.
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	120 years-old >
Gender	Male and Female
Key inclusion criteria	1) Age at the time of consent acquisition is 20 years or older 2) Among those who are refractory to MgO, those with chronic constipation according to the diagnostic criteria for functional constipation of Rome IV 3) Those who start administration of elobixibat in normal medical care 4) Persons who have obtained consent from the research subject
Key exclusion criteria	1) Patients with a history of hypersensitivity to elobixibat 2) Patients with confirmed or suspected intestinal obstruction due to tumor, hernia, etc. 3) Patients suspected of having constipation due to organic disease 4) Patients taking other laxatives 5) Others who are judged by the principal investigator to be inappropriate as research subjects
Target sample size	26

Research contact person
Name of lead principal investigator	1st name Kazuya Middle name Last name Matsumoto
Organization	Medical corporation Irisawa Medical Clinic
Division name	Internal Medicine
Zip code	690-0025
Address	285-6, Yawata-cho, Matsue 690-0025
TEL	0852-38-8211
Email	matsumotokazuya@tottori-u.ac.jp

Public contact
Name of contact person	1st name Kazuya Middle name Last name Matsumoto
Organization	Medical corporation Irisawa Medical Clinic
Division name	Internal Medicine
Zip code	690-0025
Address	285-6, Yawata-cho, Matsue 690-0025
TEL	0852-38-8211
Homepage URL
Email	matsumotokazuya@tottori-u.ac.jp

Sponsor
Institute	Medical corporation Irisawa Medical Clinic
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tottori University Hospital
Address	36-1 Nishi-cho, Yonago, 683-8504
Tel	0859-38-6527
Email	matsumotokazuya@tottori-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	2022 Year 07 Month 18 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	Enrolling by invitation
Date of protocol fixation	2022 Year 05 Month 25 Day
Date of IRB	2022 Year 07 Month 01 Day
Anticipated trial start date	2022 Year 07 Month 19 Day
Last follow-up date	2025 Year 12 Month 31 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 07 Month 18 Day
Last modified on	2022 Year 07 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055167