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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034632
Receipt No. R000039224
Scientific Title The medicinal efficacy of Elobixibat in chronic constipation with diabetes mellitus
Date of disclosure of the study information 2018/11/26
Last modified on 2019/08/30

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

Condition
Condition chronic constipation complicated with 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 chronic constipation complicated with diabetes mellitus
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference of spontaneous stool frequency in comparison before administration
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

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.
Interventions/Control_2 Patients were treated with Lubiprostone 24 micro g twice a daily, after breakfast and dinner, for 4 weeks.
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 who were 20 years-old or older and chronic constipation complicated with diabetes mellitus in Diabetes, Metabolism and Endocrinology of Kumamoto University Hospital, consenting for study paticipation.
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
Middle name
Last name Eiichi Araki
Organization Faculty of Life science,
Graduate School of Medical Sciences,
Kumamoto University
Division name Department of metabolic medicine
Zip code
Address 1-1-1, Honjo, Chuo, Kumamoto
TEL 096-373-5169
Email metab@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Norio Ishii
Organization Faculty of Life science, Graduate School of Medical Sciences, Kumamoto University
Division name Department of metabolic medicine
Zip code
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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 26 Day
Last follow-up date
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
2019 Year 08 Month 30 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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