Lead Investigator: Toshifumi Kishimoto, Nara Medical University
Title of Proposal Research: Development of the optimal treatment of Nalmefene in patients with alcohol dependence
Vivli Data Request: 7323
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Identifying who among alchohol dependence (AD) patients or problem drinkers, is best suited for Nalmefene treatment and has the greatest likelihood to control drinking. The current study and knowledege might contribute to the optimization of pharmacotherapy and the improvement of the quality of life for alcoholism and public health.
Requested Studies:
A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-parallel-group Comparison Trial to Investigate the Effect of Nalmefene on Alcohol Consumption Reduction in Patients With Alcohol Dependence (Phase 3 Trial)
Data Contributor: Otsuka Pharmaceuticals
Study ID: NCT02364947
Sponsor ID: 339-14-001
Statistical Analysis Plan:
To this end, we will use the data previously performed by the clinical trial (339-14-001) conducted in Japan (Miyata et al. 2019). An analysis of covariance would be applied to examine whether the change from baseline in the primary endpoint, such as the number of heavy drinking days (HDDs) and total amount of alcohol consumption (TAC), is significantly associated with the covariates, such as age, sex, weight, socioeconomic status, treatment history and psychiatric comorbidities. Furthermore, we will also examine whether the changes of HDDs and TAC are correlated with quality of life measures such as the CGI-S (clinical global impressions-severity of illness scale), CGI-I (clinical global impressions – global improvement), SF-36 (MOS short form 36 health survey), EQ-5D (EuroQol – 5 Dimension – 5 Level) and AQoLS (Alcohol Quality of Life Scale). Finally, if any of the above factors affect the treatment of nalmefene, we will run regression analysis and path analysis to determine the causal relationship for the effects of reducing alcohol consumption.
Summary of results:
We tried to look at the data or pull it up, but we couldn’t figure it out at all. We attempted to access and analyze the data, but unfortunately, we encountered difficulties in retrieving it. As a result, I was unable to analyze the data.