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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036655
Receipt No. R000041759
Scientific Title Efficacy and safety of Nalmefene in alcohol-dependent patients with chronic liver disease
Date of disclosure of the study information 2019/05/06
Last modified on 2019/05/05

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Basic information
Public title Efficacy and safety of Nalmefene in alcohol-dependent patients with chronic liver disease
Acronym Efficacy and safety of Nalmefene in alcohol-dependent patients
Scientific Title Efficacy and safety of Nalmefene in alcohol-dependent patients with chronic liver disease
Scientific Title:Acronym Efficacy and safety of Nalmefene in alcohol-dependent patients
Region
Japan

Condition
Condition alcohol-dependent patients
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate safety and efficacy of nalmefene in alcohol-dependent patients with alchole liver disesase.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in heavy drinking days (HDDs) after 24 weeks of treatment

Primary outcome measures were: changes in heavy drinking days (HDDs) and total alcohol consumption (TAC, g/day).
Key secondary outcomes 1) changes in drinking risk level after 24 weeks of treatment
2) changes in total alcohol consumption after 24 weeks of treatment

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 Nalmefene is administered once a day for an alcohol dependent patients treated with as-needed 10 mg nalmefene for 24 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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients diagnosed with alcohol dependence
2. Patients diagnosed with chronic liver disease
3. Male and female aged 20 years or over at the time of agreement acquisition
Key exclusion criteria 1 Patients with end-stage liver failure who have hepatic ascites, child-Pugh class BC and hepatic encephalopathy
2. Pregnant women or patients with potential pregnancy
3. Patients who research managers judged inappropriate as subjects
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Haruki
Middle name
Last name Uojima
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology, Internal Medicine
Zip code 252-0373
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa
TEL +81-42-778-8111
Email kiruha@kitasato-u.ac.jp

Public contact
Name of contact person
1st name Haruki
Middle name
Last name Uojima
Organization Kitasato University School of Medicine
Division name Department of Gastroenterology, Internal Medicine
Zip code 252-0373
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa
TEL +81-42-778-8111
Homepage URL
Email kiruha@kitasato-u.ac.jp

Sponsor
Institute Kitasato University School of Medicine
Institute
Department

Funding Source
Organization Kitasato University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kitasato University Medical Ethics Organization
Address 1-15-1 Kitasato Minami Sagamihara Kanagawa
Tel +81-42-778-8111
Email kiruha@kitasato-u.ac.jp

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
2019 Year 05 Month 06 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 14 Day
Date of IRB
2019 Year 05 Month 01 Day
Anticipated trial start date
2019 Year 05 Month 10 Day
Last follow-up date
2023 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 05 Day
Last modified on
2019 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041759

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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