UMIN-CTR Clinical Trial

Basic information
Public title	A study on the efficacy of erobixibat in patients with chronic constipation
Acronym	erobixibat trial
Scientific Title	Efficacy of erobixibat in patients with chronic constipation, examination of factors related to efficacy.
Scientific Title:Acronym	A study on the efficacy of erobixibat in patients with chronic constipation
Region	Japan

Condition
Condition	chronic constipation
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To investigate the factors related to the efficacy of erobixibat among chronic constipation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Relationship between effective and non-effective cases of erobixibat and patient background factors (age, gender, frequency of bile acid transporter expression in terminal ileum, SNP type)
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	When two or more of the following symptoms persist for 3 months or more a) less than 3 spontaneous bowels per week b) More than 25% of the stools are active c) Rabbit stool or hard stool is present in at least 25% of the bowel movement d) 25% or more of bowel movements have a feeling of residual stool d) Over 25% of bowel movements have rectal anal obstruction e) More than 25% of defecations have manual defecation promotion measures
Key exclusion criteria	(1) Intestinal obstruction due to tumor, hernia, etc. is confirmed or suspected. (2) When taking digoxin or dabigatran etexilate methanesulfonate (since these effects may be enhanced when used in combination) (3) Patients who did not agree to participate in this clinical trial (4) Those who are judged to be inappropriate as subjects by the principal investigator
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Chika Middle name Last name Kusano
Organization	Nihon University School of Medicine
Division name	Division of Gastroenterology and Hepatology, Department of Medicine
Zip code	1018309
Address	1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL	0332931711
Email	ckusano2007@yahoo.co.jp

Public contact
Name of contact person	1st name Chika Middle name Last name Kusano
Organization	Nihon University School of Medicine
Division name	Division of Gastroenterology and Hepatology, Department of Medicine
Zip code	1018309
Address	1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL	0332931711
Homepage URL
Email	ckusano2007@yahoo.co.jp

Sponsor
Institute	Nihon University School of Medicine, Division of Gastroenterology and Hepatology, Department of Medicine
Institute
Department

Funding Source
Organization	Nihon University School of Medicine, Division of Gastroenterology and Hepatology, Department of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Nihon University School of Medicine, Division of Gastroenterology and Hepatology, Department of Medicine
Address	1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
Tel	0332931711
Email	ckusano2007@yahoo.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	2020 Year 03 Month 01 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	Preinitiation
Date of protocol fixation	2020 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date	2020 Year 03 Month 01 Day
Last follow-up date	2022 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective observation study. We will entry a patient diagnosed with chronic constipation in the Nihon University Hospital within the applicable period.

Management information
Registered date	2020 Year 02 Month 28 Day
Last modified on	2020 Year 02 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045205