UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040700