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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035923
Receipt No. R000040700
Scientific Title Effectiveness of Elobixibat and Linaclotide in neurogenic bowel dysfunction due to spinal cord injury
Date of disclosure of the study information 2019/02/18
Last modified on 2019/08/22

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Basic information
Public title Effectiveness of Elobixibat and Linaclotide in neurogenic bowel dysfunction due to spinal cord injury
Acronym Effectiveness of Elobixibat and Linaclotide in neurogenic bowel dysfunction due to spinal cord injury
Scientific Title Effectiveness of Elobixibat and Linaclotide in neurogenic bowel dysfunction due to spinal cord injury
Scientific Title:Acronym Effectiveness of Elobixibat and Linaclotide in neurogenic bowel dysfunction due to spinal cord injury
Region
Japan

Condition
Condition neurogenic bowel dysfunction due to spinal cord injury
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effectiveness of 2 new laxatives (Elobixibat and Linaclotide) about managing defecation and improving QoL in patients with SCI. To also evaluate the effectiveness of combining with old agents.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Neurogenic Bowel Dysfunction score (NBD score)
MOS 36-Item Short-Form Health Survey (SF-36)
(the 2nd week in an observation period and the 1st/2nd/4th weeks after administration of new agents)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After a baseline period of two weeks, Elobixibat 10 mg is received once daily before breakfast during a treatment period of four weeks.
If any side effect occurs, the dose is reduced to half.
If the half-dose still continues to cause any adverse event, the same amount is maintained and taken every other day.
Interventions/Control_2 After a baseline period of two weeks, Linaclotide 0.5 mg is received once daily before breakfast during a treatment period of four weeks.
If any side effect occurs, the dose is reduced to half.
If the half-dose still continues to cause any adverse event, the same amount is maintained and taken every other day.
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
18 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Inpatients who are 18 years-old or older and have spinal cord injury with constipation, consenting for this study participation.
Key exclusion criteria 1. Prohibited to use new laxatives
2. Having organic constipation
3. Having no problem of defecation
4. Time since injury is less than a month.
5. Having obvious problems of cognitive function
6. Having any severe health problem
7.Judged as ineligible for this study
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Kyohei
Middle name
Last name Matsuda
Organization National Hospital Organization Murayama Medical Center
Division name Rehabilitation Medicine
Zip code 208-0011
Address 2-37-1, Gakuen, Musashimurayama-shi, Tokyo, 208-0011, Japan
TEL 042-561-1221
Email k.matsuda0112@gmail.com

Public contact
Name of contact person
1st name Kyohei
Middle name
Last name Matsuda
Organization National Hospital Organization Murayama Medical Center
Division name Rehabilitation Medicine
Zip code 208-0011
Address 2-37-1, Gakuen, Musashimurayama-shi, Tokyo, 208-0011, Japan
TEL 042-561-1221
Homepage URL
Email k.matsuda0112@gmail.com

Sponsor
Institute National Hospital Organization Murayama Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Murayama Medical Center
Address 2-37-1, Gakuen, Musashimurayama-shi, Tokyo, 208-0011, Japan
Tel 042-561-1221
Email murayamahome@hosp.go.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
2019 Year 02 Month 18 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
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 Enrolling by invitation
Date of protocol fixation
2019 Year 02 Month 01 Day
Date of IRB
2019 Year 02 Month 19 Day
Anticipated trial start date
2019 Year 02 Month 19 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 18 Day
Last modified on
2019 Year 08 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040700

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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