UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036655 |
|---|---|
| Receipt number | 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 | 2019/10/15 23:34:09 |
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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
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
kiruha@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
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
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
Open public recruiting
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 | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041759
