UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036163
Receipt number R000041191
Scientific Title Efficacy and safety of elobixibat before dinner administration in patients with functional constipation
Date of disclosure of the study information 2019/03/11
Last modified on 2019/10/11 10:43:33

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Basic information

Public title

Efficacy and safety of elobixibat before dinner administration in patients with functional constipation

Acronym

Efficacy and safety of elobixibat before dinner administration in patients with functional constipation

Scientific Title

Efficacy and safety of elobixibat before dinner administration in patients with functional constipation

Scientific Title:Acronym

Efficacy and safety of elobixibat before dinner administration in patients with functional constipation

Region

Japan


Condition

Condition

functional constipation

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We aim to examine the efficacy and safety of elobixibat before dinner administration in patients with functional constipation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of frequency of spontaneous bowel movements between baseline and week 4 of administration

Key secondary outcomes

Change of the time to first spontaneous bowel movement from baseline to 8 weeks after administration
Comparison of JPAC-QOL score between baseline and week 4 or 8 of administration
Change of Bristol Stool Form Scale (BSFS) from baseline to 8 weeks after administration
Change of VAS of abdominal pain from baseline to 8 weeks after administration
Change of frequency of spontaneous bowel movements from baseline to 8 weeks after administration
Proportion of patients who had
a spontaneous bowel movement within 24 or 48 hours after the initial administration


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 with 20 years or older at the time before administration
2. Patients who were diagnosed functional constipation by ROME IV criteria at the time before administration
3. Patients who had fewer than 3 times spontaneous bowel movements per week at the time before administration
4. Patients who were administered elobixibat before dinner during study period

Key exclusion criteria

1 Patients who were suspected of organic constipation
2 Patients who were taking constipation related medicines* within 2 weeks before elobixibat administration
3 Patients with medication history for psychotropics, antidepressants and/or anxiolytics

*Constipation related medicines
Laxatives (Magnesium oxide preparation, sodium picosulfate, sennoside, etc.)
Chinese herbal medicines having indication of constipation (Daio-kanzo-to, Choi-joki-to, Dai-saiko-to, etc.)
Therapeutic medicines of irritable bowel syndrome (Ramosetron hydrochloride, calcium polycarbophil, trimebutine maleate etc.)
Prokinetics (Mosapride citrate, metoclopramide, domperidone, etc.)

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Takeo
Middle name
Last name Odaka

Organization

ODAKA CLINIC

Division name

Director of the clinic

Zip code

275-0028

Address

1-12-3, Kanadenomori, Narashino-shi, Chiba, Japan

TEL

047-477-5525

Email

info@odaka-clinic.com


Public contact

Name of contact person

1st name Takeo
Middle name
Last name Odaka

Organization

ODAKA CLINIC

Division name

Director of the clinic

Zip code

275-0028

Address

1-12-3, Kanadenomori, Narashino-shi, Chiba, Japan

TEL

047-477-5525

Homepage URL


Email

info@odaka-clinic.com


Sponsor or person

Institute

ODAKA CLINIC

Institute

Department

Personal name



Funding Source

Organization

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

Adachikyousai Hospital Institutional Review Board

Address

1-36-8, Yanagihara, Adachi-ku, Tokyo, 120-0022, Japan

Tel

03-3881-6116

Email

yama.chike2@gmail.com


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

尾髙内科・胃腸クリニック(千葉県)


Other administrative information

Date of disclosure of the study information

2019 Year 03 Month 11 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

41

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 01 Month 17 Day

Date of IRB

2019 Year 01 Month 21 Day

Anticipated trial start date

2019 Year 01 Month 21 Day

Last follow-up date

2019 Year 02 Month 28 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 03 Month 11 Day

Last modified on

2019 Year 10 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041191


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name