UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028709 |
|---|---|
| Receipt number | R000032761 |
| Scientific Title | Comparison of drug efficacy between linaclotide and lubiprostone in constipation-predominant irritable bowel syndrome patients |
| Date of disclosure of the study information | 2017/10/01 |
| Last modified on | 2019/01/10 11:47:32 |
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Basic information
Public title
Comparison of drug efficacy between linaclotide and lubiprostone in constipation-predominant irritable bowel syndrome patients
Acronym
A clinical trial about laxative products for constipation-predominant irritable bowel syndrome
Scientific Title
Comparison of drug efficacy between linaclotide and lubiprostone in constipation-predominant irritable bowel syndrome patients
Scientific Title:Acronym
A clinical trial about laxative products for constipation-predominant irritable bowel syndrome
Region
| Japan |
Condition
Condition
constipation-predominant irritable bowel syndrome
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To compare drug efficacy of lubiprostone and linaclotide in constipation-predominant irritable bowel syndrome patients
Basic objectives2
Others
Basic objectives -Others
To evaluate association of drug efficacy with gene polymorphisms and serum cytokines
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Reduction of GSRS scores and SF-8 scores two weeks after starting medication
Key secondary outcomes
Association of drug efficacy with gene polymorphisms and serum cytokines
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
taking lubiprostone once per day for two weeks
Interventions/Control_2
taking linaclotide once ot two times per day for two weeks
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
| 16 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients diagnosed as constipation-predominant irritable bowel syndrome according to ROME 4 and who don't take lubiprostone either linaclotide
Key exclusion criteria
systemic inflammatory disease, malignancy disease, history of abdominal surgery
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiko Shiotani |
Organization
Kawasaki Medical School
Division name
Gastroenterology
Zip code
Address
577 Matsushima Kurashiki city Okayama
TEL
086-462-1111
shiotani@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Shiotani |
Organization
Kawasaki Medical School
Division name
Gastroenterology
Zip code
Address
577 Matsushima Kurashiki city Okayama
TEL
086-462-1111
Homepage URL
shiotani@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Handa clinic for Internal Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
川崎医科大学附属病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 17 | Day |
Last modified on
| 2019 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032761
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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