UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043911
Receipt number R000050099
Scientific Title Examination of elobixibat's constipation restoration effect on chronic constipation patients-Retrospective observational research-
Date of disclosure of the study information 2021/04/14
Last modified on 2022/02/08 11:24:16

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Basic information

Public title

Examination of elobixibat's constipation restoration effect on chronic constipation patients-Retrospective observational research-

Acronym

Examination of elobixibat's constipation restoration effect on chronic constipation patients

Scientific Title

Examination of elobixibat's constipation restoration effect on chronic constipation patients-Retrospective observational research-

Scientific Title:Acronym

Examination of elobixibat's constipation restoration effect on chronic constipation patients

Region

Japan


Condition

Condition

Chronic constipation

Classification by specialty

Gastroenterology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of elobixibat on reversing constipation in patients with chronic constipation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of the urge for bowel movement before and after 2 weeks of treatment by elobixibat

Key secondary outcomes

Comparison of the urge for bowel movement before and after 6 and 10 weeks of treatment by elobixibat
Satisfaction with treatment after 2, 6, and 10 weeks of treatment by elobixibat
Bowel urgency after 2, 6, and 10 weeks of treatment by elobixibat
Time from intake of elobixibat to urge for bowel movement after 2, 6, and 10 weeks of treatment by elobixibat
Comparison of stool frequency before and after 2, 6, and 10 weeks of treatment by elobixibat
Comparison of stool type on the Bristol Stool Scale before and after 2, 6, and 10 weeks of treatment by elobixibat
Improvement of abdominal bloating after 2, 6, and 10 weeks of treatment by elobixibat
Improvement of abdominal pain after 2, 6, and 10 weeks of treatment by elobixibat
Discontinuation rate of stimulative laxatives after 2, 6, and 10 weeks of treatment by elobixibat
Use of concomitant drugs for constipation
Sub-analysis by the patients' background and the treatment status of elobixibat
Incidence rate and item of adverse events and adverse drug reaction
Discontinuation rate of elobixibat


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


Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Patients 20 years or older
(2) Patients diagnosed with chronic constipation who have observation data on the urge for bowel movement from before to 2 weeks after starting treatment by elobixibat
(3) Patients who were administered elobixibat for at least 2 weeks continuously between April 19, 2018 and October 31, 2020 (Concomitant use of other drugs for the treatment of constipation should be allowed)

Key exclusion criteria

(1) Patients with a history of hypersensitivity to elobixibat
(2) Patients with confirmed or suspected bowel obstruction due to a tumor or hernia
(3) Patients with suspected constipation due to organic disease
(4) Patients who participated in a clinical trial or interventional study during the study period
(5) Patients who have been determined by a physician to be inappropriate to administer elobixibat

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Takayuki
Middle name
Last name Ishikawa

Organization

Nishi-Shinjyuku Kisaragi Clinic.

Division name

Internal medicine, Gastroenterology

Zip code

160-0023

Address

6-6-2 Nishi-Shinjuku, Shinjuku-ku, Tokyo

TEL

03-3344-0529

Email

t.ishikawa@me.com


Public contact

Name of contact person

1st name Takayuki
Middle name
Last name Ishikawa

Organization

Nishi-Shinjyuku Kisaragi Clinic.

Division name

Internal medicine, Gastroenterology

Zip code

160-0023

Address

6-6-2 Nishi-Shinjuku, Shinjuku-ku, Tokyo

TEL

03-3344-0529

Homepage URL


Email

t.ishikawa@me.com


Sponsor or person

Institute

Nishi-Shinjyuku Kisaragi Clinic.

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

Japan Conference of Clinical Research

Address

1-13-23 Minami-Ikebukuro, Toshima-ku, Tokyo

Tel

03-6869-2920

Email

nakagawa-kengo@3hcts.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

2021 Year 04 Month 14 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.shinryo-to-shinyaku.com/db/pdf/sin_0058_12_0865.pdf

Number of participants that the trial has enrolled

80

Results

The percentage of patients having defecation desire was 27.5% before the start of treatment, 76.3% at Week 2 (p<0.001), 97.0% at Week 6 (p<0.001), and 100% at Week 10.

Results date posted

2022 Year 01 Month 18 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Mean age was 35.1+-15.5 (SD) years, 83.8% (67/80) were female, and mean duration of constipation was 122.8+-99.4 (SD) months.

Participant flow


Adverse events

Adverse reactions were observed in 20 patients (25.0%), including diarrhea in 12 patients (15.0%), abdominal pain in 10 patients (12.5%), and nausea in 2 patients (2.5%). All of those were mild and non-serious.

Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2021 Year 02 Month 26 Day

Date of IRB

2021 Year 03 Month 19 Day

Anticipated trial start date

2021 Year 03 Month 25 Day

Last follow-up date

2021 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To examine the effect of elobixibat on reversing constipation in patients with chronic constipation


Management information

Registered date

2021 Year 04 Month 13 Day

Last modified on

2022 Year 02 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050099


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name