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

NCT04033094 | Completed FDA Drug

• 1 other identifier: MORPH-A-U403
• Study Type: observational
• Target: 17,566
• Locations: 1 country
• Sites: 1

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.

Conditions

Baseline Epidemiologic Assessment

Keywords

Abuse; Misuse; Overdose

Outcome Measures

Primary Outcomes (6)

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

  October 2017 through September 2020

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

  October 2017 through September 2020

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

  October 2017 through September 2020

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

  October 2017 through September 2020

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

  October 2017 through September 2020

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

  October 2017 through September 2020

Secondary Outcomes (1)

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

  October 2017 through September 2020

Study Arms (2)

MorphaBond ER

Drug: MorphaBond ER

Comparator Group

Drug: Comparator Drug

Interventions

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).

MorphaBond ER

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.

Comparator Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MorphaBond ER users and relevant comparator users

You may qualify if:

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

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Daiichi Sankyo: lead

Study Sites (1)

Daiichi Sankyo, Inc.

Basking Ridge, New Jersey, 07920, United States

Location

MeSH Terms

Conditions

Drug Overdose

Interventions

Morphine

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Safety Study Director

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 25, 2019
• Study Start: October 16, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)