Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond ER (BEAD-MB) (PMR 2961-9)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17,566
- 试验地点
- 1
- 主要终点
- Rates of addiction of MorphaBond Extended Release (ER) vs. comparators
研究概览
简要总结
The main objectives of this study are to provide surveillance/descriptive data to (a) assess utilization of MorphaBond ER and selected comparators overall and by age group and census regions using nationally-projected quarterly drug dispensing data and (b) assess the scope and pattern of abuse and clinical outcomes for MorphaBond ER using nationally representative data or data from large geographic areas in different populations.
Findings of this study will support the design of formal epidemiology assessment of the risks of addiction, overdose, and death outcomes associated with MorphaBond ER and appropriate comparators in the future.
详细描述
The study started after the launch of MorphaBond ER in October 2017 and will continue until September 2020 and the final study report will be submitted to the FDA by December 2020.
This is an observational study that will provide descriptive data on the utilization and abuse of MorphaBond ER and related outcomes (addiction, misuse, abuse, overdose, overdose-related deaths) for MorphaBond ER and selected comparators in response to the US-FDA's post-marketing requirement (PMR 2961-9 for MorphaBond ER).
No investigational products or pharmaceutical agents will be provided or administered for the purpose of this study. Multiple data sources, representing different populations and large geographic areas in the US, will be utilized to study the patterns of MorphaBond ER utilization and abuse and related outcomes.
The overall purpose of this study is to collect meaningful baseline data to support subsequent studies for formal epidemiologic assessment of abuse deterrence of MorphaBond ER as required by the FDA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •MorphaBond ER users or relevant comparator users
排除标准
- •Not applicable
研究组 & 干预措施
MorphaBond ER
干预措施: MorphaBond ER (Drug)
Comparator Group
干预措施: Comparator Drug (Drug)
结局指标
主要结局
Rates of addiction of MorphaBond Extended Release (ER) vs. comparators
时间窗: October 2017 through September 2020
Overdose rates of MorphaBond Extended Release (ER) vs. comparators
时间窗: October 2017 through September 2020
Overall mortality rates and opioid overdose death rates of MorphaBond Extended Release (ER) vs. comparators
时间窗: October 2017 through September 2020
Quarterly number of MorphaBond Extended Release (ER) dosage unit dispensed
时间窗: October 2017 through September 2020
Percentage and rates of abuse/abuse-related outcomes of MorphaBond Extended Release (ER) vs. comparators
时间窗: October 2017 through September 2020
Rates of misuse of MorphaBond Extended Release (ER) vs. comparators
时间窗: October 2017 through September 2020
次要结局
- Number and proportion of abuse-related outcomes by routes of administration (e.g. ingestion, inhalation, etc).(October 2017 through September 2020)