UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044990 |
|---|---|
| Receipt number | R000051401 |
| Scientific Title | Exploratory Study on Modifiers of the Effect of Nalmefene in Reducing Alcohol Consumption in Patients with Alcoholism on the Basis of Genetic Factors |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2025/11/19 16:44:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Exploratory Study on Modifiers of the Effect of Nalmefene in Reducing Alcohol Consumption in Patients with Alcoholism on the Basis of Genetic Factors
Acronym
Exploratory Study on Modifiers of the Effect of Nalmefene in Reducing Alcohol Consumption on the Basis of Genetic Factors
Scientific Title
Exploratory Study on Modifiers of the Effect of Nalmefene in Reducing Alcohol Consumption in Patients with Alcoholism on the Basis of Genetic Factors
Scientific Title:Acronym
Exploratory Study on Modifiers of the Effect of Nalmefene in Reducing Alcohol Consumption on the Basis of Genetic Factors
Region
| Japan |
Condition
Condition
alcoholism
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To identify the loci of the genes encoding the effect modifiers for nalmefene by using genetic polymorphisms.
Basic objectives2
Others
Basic objectives -Others
To identify the loci of the genes encoding the effect modifiers for nalmefene by using genetic polymorphisms.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Information on genetic polymorphisms
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who participated in the phase 3 study of the following clinical study and provide consent to the retention of their DNA: A multicenter, randomized, double-blind, placebo-controlled,3-parallel-group study(339-14-001) to verify the effect of nalmefene in reducing alcohol consumption in patients with alcoholism.
Subjects who has a drug efficacy data on 12-week time point.
Key exclusion criteria
None
Target sample size
540
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Takagi |
Organization
Okayama University Hospital
Division name
Department of Neuropsychiatry
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kitaku, Okayama, Japan
TEL
086-235-7242
manabuta@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Izuru |
| Middle name | |
| Last name | Nakamura |
Organization
Otsuka Pharmaceutical Co., Ltd
Division name
Medical Affairs
Zip code
108-8242
Address
Shinagawa Grand Central Tower 2-16-4 Konan, Minato-ku, Tokyo
TEL
03-6717-1400
Homepage URL
Nakamura.Izuru@otsuka.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Otsuka Pharmaceutical Co., Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The research ethics committee of Otsuka Pharmaceutical Co., Ltd
Address
463-10 Kagasuno,Kawauchi-cho,Tokushima-city,Tokushima
Tel
088-665-2126
Suzuki.Takashi@otsuka.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
| 2021 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/add.70160?af=R
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/add.70160?af=R
Number of participants that the trial has enrolled
539
Results
In the analysis of interactions between genetic polymorphisms and treatment groups, no significant association between treatment status and SNPs was identified for efficacy endpoints. However, SNPs suggesting an association with efficacy endpoints were identified.
Furthermore, additional analyses revealed that carriers of the A allele of ADH1B rs1229984, a genetic polymorphism widely observed in Asians including Japanese individuals, showed the strongest response to nalmefene.
Results date posted
| 2025 | Year | 11 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A subset of 531 individuals (mean age 49.2 years, standard deviation 11.5; 69.9% male), including 196 in the placebo group and 335 in the nalmefene group, who agreed to DNA preservation and had available DNA data between February 2015 and July 2016.
Participant flow
Secondary analysis of a Japanese randomized clinical trial, in which participants were randomly assigned (4:3:4) to placebo, 10 mg nalmefene or 20 mg nalmefene groups for 24 weeks, accompanied by a brief psychosocial intervention.
Adverse events
N/A
Outcome measures
Genotyping was performed to determine ADH1B rs1229984 polymorphism (AA, AG, GG) and ALDH2 rs671 polymorphism (GG, GA, AA) in participants. Primary endpoint was change from baseline in monthly heavy drinking days (HDD, days/month) over the 24 treatment weeks. The key secondary endpoint was change from baseline in daily total alcohol consumption (TAC, g/day) over the 24 treatment weeks.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
identify the loci of the genes encoding the effect modifiers for nalmefene by using genetic polymorphisms.
Management information
Registered date
| 2021 | Year | 07 | Month | 29 | Day |
Last modified on
| 2025 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051401
