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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028709
Receipt No. 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

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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
Email 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
Email shiotani@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032761

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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