UMIN-CTR Clinical Trial

Basic information
Public title	The medicinal efficacy of Elobixibat in chronic constipation with type 2 diabetes mellitus
Acronym	The medicinal efficacy of Elobixibat in chronic constipation with type 2 diabetes mellitus
Scientific Title	The medicinal efficacy of Elobixibat in chronic constipation with type 2 diabetes mellitus
Scientific Title:Acronym	The medicinal efficacy of Elobixibat in chronic constipation with type 2 diabetes mellitus
Region	Japan

Condition
Condition	chronic constipation complicated with type 2 diabetes mellitus
Classification by specialty	Gastroenterology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the medicinal efficacy of Elobixibat in patients with chronic constipation complicated with type 2 diabetes mellitus
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The goal of this study is to evaluate the non-inferiority of elobixibat to lubiprostone. To ensure it, We compare the number of defecation with no laxatives in a week that passed firstly from which they started to take the drugs between two groups who take one of those drugs.
Key secondary outcomes	1. The frequency of spontaneous defecation (times/ week), in which firstly patients take test drugs. 2. The frequency of spontaneous defecation (times/ week) a week after their first administration of test drugs. 3. The frequency of spontaneous defecation (times/ 4 weeks) in whole administration period (4 weeks). 4. The frequency of spontaneous defecation (times/ week) with no sensation of incomplete evacuation in 2 weeks which have passed from their first administration of test drugs. 5. The difference of the frequency (times/ week) in which they defecate spontaneously between the weeks before and after they have taken test drugs. 6. The difference of the frequency (times/ week) in which they defecate spontaneously with no sensation of incomplete evacuation between the weeks before and after they have taken test drugs. 7. The change of the hardness of stools which were classified by Bristol Stool Chart. 8. The frequency of rescue dose. If they have no defecation for 72 hours among this study, bisacodyl suppositories 10 mg daily could be used. 9. The happiness of patients evaluated by visual analogue scale. 10. The compliance of taking test drugs (times/ 2 weeks). 11. Any adverse events, and unexpected changes of laboratory data and vital signs.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients were treated with Elobixibat 10 mg once daily before breakfast for 4 weeks. The dosage were fixed among the former 2 weeks, and could be changed from 2.5 mg up to 15 mg daily among the latter 2 weeks, if doctors needed to change it.
Interventions/Control_2	Patients were treated with Lubiprostone 24 micro g twice a day, after breakfast and dinner, for 4 weeks. The dosage were fixed among the former 2 weeks, and could be changed from 16 micro g up to 48 micro g daily among the latter 2 weeks, if doctors needed to change it.
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	Outpatients or hospitalized patients in Diabetes, Metabolism and Endocrinology of Kumamoto University Hospital, who were 20 years-old or older, suffering from chronic constipation complicated with type 2 diabetes mellitus, consenting for study paticipation. The drugs for constipation taken before this study would be stopped to be taken, except for Magnesium oxide when they participated in this study. Attending physician would select the continuation or discontinuation of taking Magnesium oxide among this study.
Key exclusion criteria	Patients meeting the following criteria will be excluded from the study: 1. Patients with infectious disease in acute phase, who had fever, or signs as getting cold 2. Patients who had past histories of surgeries of ileus, or hospitalization by ileus. 3. Patients with the constipation associated with colon cancers, rectul cancers, or resection of colonal polyps, including polypectomy 4. Patients with cardiovascular or cerebrovascular diseases occured within 12 weeks before the registration of this study 5. Patients with hepatic disfunction as the state of B or C in classification of Child-Pugh at the registration of this study 6. Patients with renal disfunction, which eGFR were lower than 30 ml/min/1.73m2 at the registration of this study 7. Patients with severe respiratory diseases,heart failure or arrhythmia. 8. Patients with mental disorder. 9. Patients who are pregnant or might be pregnant 10. Patients whom the physician in charge judges to be unsuitable for any other reason.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Eiichi Middle name Last name Araki
Organization	Faculty of Life science, Graduate School of Medical Sciences, Kumamoto University
Division name	Department of metabolic medicine
Zip code	860-8556
Address	1-1-1, Honjo, Chuo, Kumamoto
TEL	096-373-5169
Email	cpfx_774neo@yahoo.co.jp

Public contact
Name of contact person	1st name Norio Middle name Last name Ishii
Organization	Faculty of Life science, Graduate School of Medical Sciences, Kumamoto University
Division name	Department of metabolic medicine
Zip code	860-8556
Address	1-1-1, Honjo, Chuo, Kumamoto
TEL	096-373-5169
Homepage URL
Email	ishii-n@kumamoto-u.ac.jp

Sponsor
Institute	Department of metabolic medicine, Faculty of Life science, Graduate School of Medical Sciences, Kumamoto University
Institute
Department

Funding Source
Organization	Department of metabolic medicine Graduate School of Medical Sciences, Kumamoto University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	The centor for clinical research of kumamoto university hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kumamoto university independent ethics committee
Address	1-1-1 Honjo Chuo-Ku, Kumamoto 860-8556, Japan
Tel	096-373-5657
Email	iyg-igaku@jimu.kumamoto-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	熊本大学病院

Other administrative information
Date of disclosure of the study information	2018 Year 11 Month 26 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	2018 Year 11 Month 26 Day
Date of IRB	2019 Year 06 Month 17 Day
Anticipated trial start date	2019 Year 10 Month 10 Day
Last follow-up date	2024 Year 03 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	2018 Year 10 Month 24 Day
Last modified on	2022 Year 05 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039224