Clinical trial NCT04033094: Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond Extended Release (BEAD-MB)
Official title: Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond ER (BEAD-MB) (PMR 2961-9)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Baseline Epidemiologic Assessment
Keywords: Abuse
Misuse
Overdose
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2019-07-25
Enrollment: 17566
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MorphaBond ER users and relevant comparator users

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Male or female
* MorphaBond ER users or relevant comparator users

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Quarterly number of MorphaBond Extended Release (ER) dosage unit dispensed
timeFrame: October 2017 through September 2020
measure: Percentage and rates of abuse/abuse-related outcomes of MorphaBond Extended Release (ER) vs. comparators
timeFrame: October 2017 through September 2020
measure: Rates of misuse of MorphaBond Extended Release (ER) vs. comparators
timeFrame: October 2017 through September 2020
measure: Rates of addiction of MorphaBond Extended Release (ER) vs. comparators
timeFrame: October 2017 through September 2020
measure: Overdose rates of MorphaBond Extended Release (ER) vs. comparators
timeFrame: October 2017 through September 2020
measure: Overall mortality rates and opioid overdose death rates of MorphaBond Extended Release (ER) vs. comparators
timeFrame: October 2017 through September 2020
Secondary outcomes:
measure: Number and proportion of abuse-related outcomes by routes of administration (e.g. ingestion, inhalation, etc).
timeFrame: October 2017 through September 2020
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Daiichi Sankyo, Inc.
state: New Jersey
Study officials:
affiliation: Daiichi Sankyo
name: Safety Study Director
role: STUDY_DIRECTOR
References: