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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000048050 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | alcoholic liver injury | |
Classification by specialty |
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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.
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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 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Nara medical university Hospital
Department of Gastroenterology |
Institute | |
Department |
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 |
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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 | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Other | |
Other related information | not paticular |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053011 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |