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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
