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

NCT04033094 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 17566

Last updated 2021-03-15

No results posted yet for this study

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

Interventions

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).

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • Safety Study Director · Daiichi Sankyo

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04033094 on ClinicalTrials.gov