UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy Evaluation of Lubiprostone on Non-Alcoholic Fatty Liver Disease (NAFLD)wih constipation: LUBIPRONE, Proof of Concept(POC) Study.
Acronym	LUBIPRONE, Proof of Concept(POC) Study.
Scientific Title	Efficacy Evaluation of Lubiprostone on Non-Alcoholic Fatty Liver Disease (NAFLD)wih constipation: LUBIPRONE, Proof of Concept(POC) Study.
Scientific Title:Acronym	LUBIPRONE, Proof of Concept(POC) Study.
Region	Japan

Condition
Condition	Non-Alcoholic Fatty Liver Disease (NAFLD) in Constipated Patients
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Efficacy Evaluation of Lubiprostone on Non-Alcoholic Fatty Liver Disease (NAFLD) in Constipated Patients
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change from baseline in ALT at Week 12
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Placebo
Interventions/Control_2	Lubiprostone 12 mcg group
Interventions/Control_3	Lubiprostone 24 mcg group
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Patients aged between 20 years and 85 years (both inclusive) at the time of informed consent 2)Patients with NAFLD which did not respond to 3-month diet and exercise therapy 3)Patients with constipation in the past or now (diagnostic criteria: Rome4) 4)Patients who are able to provide written consent to participate in this research in person, follow instructions during participation in this research, and undergo protocol-specified physical examination and other examinations, and report symptoms or events 5)Patients with a diagnosis of fatty liver based on abdominal ultrasonography 6)Patients with S1, S2, S3 fatty liver or equivalent on TE (using FibroScan) or MRI/MRS 7)Patients with F1, F2, or F3 fibrosis or equivalent on TE (FibroScan) or MRE 8)Patients with an ALT level of more than 40 IU/L at the start of this study 9)Patients with no habitual alcohol consumption (i.e., consumption of ethanol less than 30 g/day in men and less than 20 g/day in women)
Key exclusion criteria	1)Patients with any change to their oral medications within 3 months before informed consent 2)Patients with any contraindications listed on the package insert for lubiprostone or with a history of hypersensitivity to any ingredients of lubiprostone 3)Patients with any other concurrent liver disease, such as hepatitis C, hepatitis B, or autoimmune hepatitis 4)Patients with concurrent or past history of any serious cardiac, vascular, hematological, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatry disease 5)Patients with drug-induced, symptomatic NAFLD 6)Patients who participated in any other clinical study and received study treatment within 1 month before the start of this research (counted from the first day of study medication) 7)Patients with diabetes mellitus being treated with insulin injections 8)Patients with a history of abdominal or gastrointestinal surgery, with the exception of appendicitis 9)Breastfeeding women, or women with possible pregnancy 10)Other patients who are inappropriate as participants in this research in the opinion of the principal investigator etc.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Middle name Last name Atsushi Nakajima
Organization	Yokohama University School of Medicine
Division name	Gastroenterology and Hepatology
Zip code
Address	3-9 A-467 Fuku-ura, Kanazawa-ku, Yokohama, 236-0004
TEL	045-787-2640
Email	nakajima-tky@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takaomi Kessoku
Organization	Yokohama University School of Medicine
Division name	Gastroenterology and Hepatology
Zip code
Address	3-9 A-467 Fuku-ura, Kanazawa-ku, Yokohama, 236-0004
TEL	045-787-2640
Homepage URL
Email	takaomi0027@gmail.com

Sponsor
Institute	Yokohama University School of Medicine
Institute
Department

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

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

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 22 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	2016 Year 09 Month 04 Day
Date of IRB	2016 Year 11 Month 21 Day
Anticipated trial start date	2017 Year 03 Month 24 Day
Last follow-up date	2018 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete	2018 Year 10 Month 10 Day
Date analysis concluded	2019 Year 03 Month 21 Day

Other
Other related information

Management information
Registered date	2017 Year 03 Month 21 Day
Last modified on	2021 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030584