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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030327
Receipt No. R000034635
Scientific Title Proof-of-concept clinical trial of lubiprostone's effect on chronic enteropathy associated with SLCO2A1
Date of disclosure of the study information 2017/12/22
Last modified on 2019/03/28

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Basic information
Public title Proof-of-concept clinical trial of lubiprostone's effect on chronic enteropathy associated with SLCO2A1
Acronym LEAC study
Scientific Title Proof-of-concept clinical trial of lubiprostone's effect on chronic enteropathy associated with SLCO2A1
Scientific Title:Acronym LEAC study
Region
Japan

Condition
Condition Nonspecific multiple ulcers in the small intestine unrelated to NSAID (Chronic enteropathy associated with SLCO2A1: CEAS)
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To determine the lubiprostones's effect on CEAS by using double-balloon enteroscopy and probe-based confocal endomicroscopy in addition to blood, urine, and stool tests and patholgical change.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes 1) Enteroscopic improvement after lubiprotone treatment
2) Endocmicroscopic improvement of leaky gut syndrome
Key secondary outcomes 1)Serum iron, ferritin, total protein, and albumin
2) Urine PGE-MUM/Cr
3) Fecal calprotectin
4) Oter blood test data
5) Symptomatic improvement
6) Pathologic change
7) Bowel movements

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 lubiprostone(12 micrograms) for 8 weeks
Interventions/Control_2
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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Patients with CEAS who provide informed consent.
Key exclusion criteria 1) Contraindications of enteroscopy
2) Bad conditions such as small bowel obstruction
3) Severe cardiac or pulmonary disease
4) Allergy to lubiprostone or contraindications of lubiprostone
5) Within 1 month of another clinical trial
6) Pregnant or lactating women
7) Man or woman who does not comply with this trial
8) Inappropriate situations judged by attending doctors
Target sample size 8

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Ohmiya
Organization Fujita Health University
Division name Department of Gastroenterology
Zip code
Address 1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL 0562-93-9240
Email nohmiya@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Ohmiya
Organization Fujita Health University
Division name Department of Gastroenterology
Zip code
Address 1-98 Dengakugakubo Kutsukake-cho, Toyoake, Aichi
TEL 0562-93-9240
Homepage URL
Email nohmiya@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University, Department of Gastroenterology
Institute
Department

Funding Source
Organization Mylan EPD G.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 藤田保健衛生大学病院(愛知県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 22 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 4
Results
1. Lubiprostone should be carefully prescribed especially to patients with small bowel stenosis.
2. The enteroscopic improvement with 12 microgram of lubiprostone was limited in patietns with CEAS.
3. Electron microscopy revealed the increased volume of water between cells by administration of lubiprostone with intact tight junction.
Results date posted
2019 Year 03 Month 28 Day
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 06 Month 09 Day
Date of IRB
2017 Year 06 Month 09 Day
Anticipated trial start date
2017 Year 12 Month 25 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 20 Day
Date trial data considered complete
2019 Year 03 Month 27 Day
Date analysis concluded
2019 Year 03 Month 28 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 09 Day
Last modified on
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034635

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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