UMIN-CTR Clinical Trial

Basic information
Public title	Examination of elobixibat's constipation restoration effect on chronic constipation patients-Retrospective observational research-
Acronym	Examination of elobixibat's constipation restoration effect on chronic constipation patients
Scientific Title	Examination of elobixibat's constipation restoration effect on chronic constipation patients-Retrospective observational research-
Scientific Title:Acronym	Examination of elobixibat's constipation restoration effect on chronic constipation patients
Region	Japan

Condition
Condition	Chronic constipation
Classification by specialty	Gastroenterology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of elobixibat on reversing constipation in patients with chronic constipation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of the urge for bowel movement before and after 2 weeks of treatment by elobixibat
Key secondary outcomes	Comparison of the urge for bowel movement before and after 6 and 10 weeks of treatment by elobixibat Satisfaction with treatment after 2, 6, and 10 weeks of treatment by elobixibat Bowel urgency after 2, 6, and 10 weeks of treatment by elobixibat Time from intake of elobixibat to urge for bowel movement after 2, 6, and 10 weeks of treatment by elobixibat Comparison of stool frequency before and after 2, 6, and 10 weeks of treatment by elobixibat Comparison of stool type on the Bristol Stool Scale before and after 2, 6, and 10 weeks of treatment by elobixibat Improvement of abdominal bloating after 2, 6, and 10 weeks of treatment by elobixibat Improvement of abdominal pain after 2, 6, and 10 weeks of treatment by elobixibat Discontinuation rate of stimulative laxatives after 2, 6, and 10 weeks of treatment by elobixibat Use of concomitant drugs for constipation Sub-analysis by the patients' background and the treatment status of elobixibat Incidence rate and item of adverse events and adverse drug reaction Discontinuation rate of elobixibat

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 20 years or older (2) Patients diagnosed with chronic constipation who have observation data on the urge for bowel movement from before to 2 weeks after starting treatment by elobixibat (3) Patients who were administered elobixibat for at least 2 weeks continuously between April 19, 2018 and October 31, 2020 (Concomitant use of other drugs for the treatment of constipation should be allowed)
Key exclusion criteria	(1) Patients with a history of hypersensitivity to elobixibat (2) Patients with confirmed or suspected bowel obstruction due to a tumor or hernia (3) Patients with suspected constipation due to organic disease (4) Patients who participated in a clinical trial or interventional study during the study period (5) Patients who have been determined by a physician to be inappropriate to administer elobixibat
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Takayuki Middle name Last name Ishikawa
Organization	Nishi-Shinjyuku Kisaragi Clinic.
Division name	Internal medicine, Gastroenterology
Zip code	160-0023
Address	6-6-2 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL	03-3344-0529
Email	t.ishikawa@me.com

Public contact
Name of contact person	1st name Takayuki Middle name Last name Ishikawa
Organization	Nishi-Shinjyuku Kisaragi Clinic.
Division name	Internal medicine, Gastroenterology
Zip code	160-0023
Address	6-6-2 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL	03-3344-0529
Homepage URL
Email	t.ishikawa@me.com

Sponsor
Institute	Nishi-Shinjyuku Kisaragi Clinic.
Institute
Department

Funding Source
Organization	MOCHIDA PHARMACEUTICAL CO., LTD., 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	Japan Conference of Clinical Research
Address	1-13-23 Minami-Ikebukuro, Toshima-ku, Tokyo
Tel	03-6869-2920
Email	nakagawa-kengo@3hcts.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

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 14 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.shinryo-to-shinyaku.com/db/pdf/sin_0058_12_0865.pdf
Number of participants that the trial has enrolled	80
Results	The percentage of patients having defecation desire was 27.5% before the start of treatment, 76.3% at Week 2 (p<0.001), 97.0% at Week 6 (p<0.001), and 100% at Week 10.
Results date posted	2022 Year 01 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Mean age was 35.1+-15.5 (SD) years, 83.8% (67/80) were female, and mean duration of constipation was 122.8+-99.4 (SD) months.
Participant flow
Adverse events	Adverse reactions were observed in 20 patients (25.0%), including diarrhea in 12 patients (15.0%), abdominal pain in 10 patients (12.5%), and nausea in 2 patients (2.5%). All of those were mild and non-serious.
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2021 Year 02 Month 26 Day
Date of IRB	2021 Year 03 Month 19 Day
Anticipated trial start date	2021 Year 03 Month 25 Day
Last follow-up date	2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To examine the effect of elobixibat on reversing constipation in patients with chronic constipation

Management information
Registered date	2021 Year 04 Month 13 Day
Last modified on	2022 Year 02 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050099