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

Baseline Epidemiologic Assessment Clinical Trial

— BEAD-MB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04033094
• Other study ID #: MORPH-A-U403
• Status: Completed
• Start date: October 16, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17566
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Male or female

• MorphaBond ER users or relevant comparator users

Exclusion Criteria:

• Not applicable

Related Conditions & MeSH terms

• Baseline Epidemiologic Assessment

Intervention

Drug:
• MorphaBond ER
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
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.

Locations

Country	Name	City	State
United States	Daiichi Sankyo, Inc.	Basking Ridge	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quarterly number of MorphaBond Extended Release (ER) dosage unit dispensed		October 2017 through September 2020
Primary	Percentage and rates of abuse/abuse-related outcomes of MorphaBond Extended Release (ER) vs. comparators		October 2017 through September 2020
Primary	Rates of misuse of MorphaBond Extended Release (ER) vs. comparators		October 2017 through September 2020
Primary	Rates of addiction of MorphaBond Extended Release (ER) vs. comparators		October 2017 through September 2020
Primary	Overdose rates of MorphaBond Extended Release (ER) vs. comparators		October 2017 through September 2020
Primary	Overall mortality rates and opioid overdose death rates of MorphaBond Extended Release (ER) vs. comparators		October 2017 through September 2020
Secondary	Number and proportion of abuse-related outcomes by routes of administration (e.g. ingestion, inhalation, etc).		October 2017 through September 2020