UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048050 |
|---|---|
| Receipt number | R000053011 |
| Scientific Title | Effects of nalmefen on alcohol consumption in patients with alcoholic liver injury and alcohol-dependent patients |
| Date of disclosure of the study information | 2022/06/15 |
| Last modified on | 2022/06/15 13:08:02 |
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Basic information
Public title
Effects of nalmefen on alcohol consumption in patients with alcoholic liver injury and alcohol-dependent patients
Acronym
Effects of nalmefen in patients with alcoholic liver injury and alcohol-dependent patients
Scientific Title
Effects of nalmefen on alcohol consumption in patients with alcoholic liver injury and alcohol-dependent patients
Scientific Title:Acronym
Effects of nalmefen in patients with alcoholic liver injury and alcohol-dependent patients
Region
| Japan |
Condition
Condition
alcoholic liver injury
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, the option of a reduced drinking setting (harm reduction) has been presented as an intermediate goal for patients who need to abstain from alcohol, and nalmefene was approved as a drinking reduction drug in January 2019. There are few reports that have comprehensively investigated the effects of nalmefene in alcoholic patients with alcoholic liver disease from both central and peripheral organs. In addition, the FRQ of the 3rd edition of the Guidelines for the Treatment of Cirrhosis states that the effect of harm reduction in patients with alcoholic cirrhosis needs to be investigated. In the present study, we will investigate the effects of nalmefene on the treatment of alcohol-related liver disorders, including alcoholic cirrhosis, and the factors associated with these effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Liver reserve capacity at each time point.
Key secondary outcomes
Various blood biochemical indices related to liver injury (continuous variables)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. patients whose eligibility for treatment with nalmefene has been determined as the best treatment in the usual course of practice
2. patients between 20 and 80 years of age, regardless of gender
3. patients who have been diagnosed by a physician who has taken the training required of physicians when calculating the additional fee for inpatient medical management of severe alcoholism or the "e-learning training on the diagnosis and treatment of alcoholism" organized by the Japanese Society of Alcoholism and Alcohol Abuse Medicine and the Japanese Society of Hepatology. Patients with alcoholic liver disease (hepatic reserve of less than 10 points in Child-Pugh score) 4.
4. patients with a drinking risk level (DRL) of high or very high for more than 2 weeks
5. patients willing to receive ongoing psychosocial supportive therapy focused on treatment compliance and alcohol consumption reduction
Key exclusion criteria
1. patients under 19 years old and over 80 years old
2. patients with physical withdrawal symptoms
3. Patients with cancer
4. Pregnant and lactating patients
5. patients using opioids other than nalmefene
6. Patients with severely impaired renal function (eGFR<30 ml/min/1.73m2)
7. Patients who have indicated their refusal to participate in the study
8. dementia (PS2 or higher)
9. patients with psychosis other than alcohol use dependence, who are regularly attending or being hospitalized by a neuropsychiatrist, and who are considered to be difficult to participate in the study
10. other patients who are judged to be ineligible by the investigators and subinvestigators of this study
11. Patients with other addictions
12. patients with intellectual disabilities
13. patients with cerebral organic mental disorder
14. patients with a history of taking Nalmefene (Nalmefene reinstatement)
15. patients with a history of treatment for alcohol dependence at a medical institution specializing in addiction
16. patients with psychiatric disorders other than alcohol dependence
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Yoshiji |
Organization
Nara medical university Hospital
Division name
Department of Gastroenterology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara Nara
TEL
0744223051
tadashin@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Namisaki |
Organization
Nara medical university Hospital
Division name
Department of Gastroenterology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara Nara
TEL
0744223051
Homepage URL
tadashin@naramed-u.ac.jp
Sponsor or person
Institute
Nara medical university Hospital
Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
self-financing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara medical university Hospital
Address
840 Shijo-cho, Kashihara Nara
Tel
0744223051
tadashin@naramed-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
| 2022 | Year | 06 | Month | 15 | 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
| 2022 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not paticular
Management information
Registered date
| 2022 | Year | 06 | Month | 14 | Day |
Last modified on
| 2022 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000053011
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