UMIN-CTR Clinical Trial

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

chronic constipation complicated with type 2 diabetes mellitus

Classification by specialty

Gastroenterology

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Department of metabolic medicine
Graduate School of Medical Sciences, Kumamoto University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

The centor for clinical research of kumamoto university hospital

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

熊本大学病院

Date of disclosure of the study information

2018

Year

11

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2018

Year

10

Month

24

Day

Last modified on

2022

Year

05

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039224