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Completed

NCT Number: NCT04033094

Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond Extended Release (BEAD-MB)

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.

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Key information

Conditions

Baseline Epidemiologic Assessment Chemically-Induced Disorders Drug Misuse Drug Overdose Mental Disorders Prescription Drug Misuse Substance-Related Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

Daiichi Sankyo, Inc.

Basking Ridge, New Jersey, 07920, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Not applicable

Treatment and study plan

MorphaBond ER

Drug

This was a retrospective, non-interventional study. Previous users of branded and generic products (tablets or capsules) with ER and immediate release (IR) release type formulations of oxycodone, oxymorphone, hydromorphone and morphine (except MorphaBond).

Comparator Drug

Drug

This was a retrospective, non-interventional study. Previous users of the MorphaBond ER brand of ER morphine sulfate with A-D labeling, by prescription or non-prescription.

Primary outcomes

  1. Quarterly number of MorphaBond Extended Release (ER) dosage unit dispensed

    Time frame: October 2017 through September 2020

  2. Percentage and rates of abuse/abuse-related outcomes of MorphaBond Extended Release (ER) vs. comparators

    Time frame: October 2017 through September 2020

  3. Rates of misuse of MorphaBond Extended Release (ER) vs. comparators

    Time frame: October 2017 through September 2020

  4. Rates of addiction of MorphaBond Extended Release (ER) vs. comparators

    Time frame: October 2017 through September 2020

  5. Overdose rates of MorphaBond Extended Release (ER) vs. comparators

    Time frame: October 2017 through September 2020

  6. Overall mortality rates and opioid overdose death rates of MorphaBond Extended Release (ER) vs. comparators

    Time frame: October 2017 through September 2020

Secondary outcomes

  1. Number and proportion of abuse-related outcomes by routes of administration (e.g. ingestion, inhalation, etc).

    Time frame: October 2017 through September 2020

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond ER (BEAD-MB) (PMR 2961-9)

Acronym: BEAD-MB

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 25, 2019
Registry last updated
Mar 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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