UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037286
Receipt number R000042505
Scientific Title Efficacy and safety of elobixibat in elderly patients with chronic constipation in clinical practice
Date of disclosure of the study information 2019/07/05
Last modified on 2020/03/03 13:48:21

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Basic information

Public title

Efficacy and safety of elobixibat in elderly patients with chronic constipation in clinical practice -Retrospective observation research-

Acronym

Efficacy and safety of elobixibat in elderly patients with chronic constipation in clinical practice

Scientific Title

Efficacy and safety of elobixibat in elderly patients with chronic constipation in clinical practice

Scientific Title:Acronym

Efficacy and safety of elobixibat in elderly patients with chronic constipation in clinical practice

Region

Japan


Condition

Condition

Chronic constipation

Classification by specialty

Gastroenterology Geriatrics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine efficacy and safety of elobixibat using Constipation Scoring Systemin (CSS) in elderly patients with chronic constipation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of CSS total score between baseline and at weeks 2 of administration

Key secondary outcomes

Comparison of CSS sub score sbetween baseline and at weeks 2 of administration
Comparison of Bristol Stool Form Scale (BSFS) between baseline and at weeks 2 of administration
etc.


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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with 65 years or older
2. Patients with chronic constipation who must include 2 or more the following 6 items
a. Straining during more than one-fourth of defecations
b. Lumpy or hard stools (BSFS 1or 2) more than one-fourth of defecations
c. Sensation of incomplete evacuation more than one-fourth of defecations
d.Sensation of anorectal obstruction/blockage more than
one-fourth of defecations
e. Manual maneuvers to facilitate more than one fourth of defecations
f. Fewer than 3 spontaneous bowel movements per week
3. Patients who starts Elobixibat administration from April 19, 2018 to March 31, 2019 (including concomitant use with other constipation drugs)

Key exclusion criteria

1. Patients who had a history of hypersensitivity of elobixibat
2. Patients who are confirmed or suspected intestinal obstruction due to tumor, hernia etc.
3. Patients who are suspected constipation due to organic disease
4. Patients whose physicians judged that administration of elobixibat was inappropriate

Target sample size

160


Research contact person

Name of lead principal investigator

1st name Abe
Middle name
Last name Tatsuya

Organization

Kunimoto Hospital

Division name

Director

Zip code

070-0061

Address

7-2-1, Akebono1-jo, Asahikawa Shi, Hokkaido, Japan

TEL

0166-25-2241

Email

abetatsuya99@gmail.com


Public contact

Name of contact person

1st name Abe
Middle name
Last name Tatsuya

Organization

Kunimoto Hospital

Division name

Director

Zip code

070-0061

Address

7-2-1, Akebono1-jo, Asahikawa Shi, Hokkaido, Japan

TEL

0166-25-2241

Homepage URL


Email

abetatsuya99@gmail.com


Sponsor or person

Institute

Kunimoto Hospital

Institute

Department

Personal name



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

Yamauchi Clinic IRB

Address

1-15-19, Jiyugaoka, Meguro Ku, Tokyo To, Japan

Tel

03-5575-5862

Email

c-irb_ug@neues.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

医療法人健康会 くにもと病院(北海道)


Other administrative information

Date of disclosure of the study information

2019 Year 07 Month 05 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

160

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

Completed

Date of protocol fixation

2019 Year 05 Month 29 Day

Date of IRB

2018 Year 06 Month 25 Day

Anticipated trial start date

2019 Year 07 Month 02 Day

Last follow-up date

2019 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

nothing


Management information

Registered date

2019 Year 07 Month 05 Day

Last modified on

2020 Year 03 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042505


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name