UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035923 |
|---|---|
| Receipt number | 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 | 2020/02/20 13:19:34 |
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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
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
k.matsuda0112@gmail.com
Sponsor or person
Institute
National Hospital Organization Murayama Medical Center
Institute
Department
Personal name
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
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
Terminated
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
| 2020 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040700
