UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026635 |
|---|---|
| Receipt number | R000030584 |
| Scientific Title | Efficacy Evaluation of Lubiprostone on Non-Alcoholic Fatty Liver Disease (NAFLD)wih constipation: LUBIPRONE, Proof of Concept(POC) Study. |
| Date of disclosure of the study information | 2017/03/22 |
| Last modified on | 2021/08/29 12:33:06 |
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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
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
takaomi0027@gmail.com
Sponsor or person
Institute
Yokohama University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030584
