Baseline Epidemiologic AssessmentBEAD-MBNCT04033094
Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond Extended Release (BEAD-MB)
An observational study of Baseline Epidemiologic Assessment, run by Daiichi Sankyo at 1 site in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Baseline Epidemiologic Assessment
- What is being tested?
- MorphaBond ER and Comparator Drug
- Type of treatment
- Pill or oral medicine
- How many people
- 17,566 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2017to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: MorphaBond ER users and relevant comparator users
Who may be able to join
- Male or female
- MorphaBond ER users or relevant comparator users
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
United States1 site
Daiichi Sankyo, Inc.
Basking Ridge, New Jersey, 07920
About this study
Official title: Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond ER (BEAD-MB) (PMR 2961-9)
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.
Read the 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.
- Conditions
- Baseline Epidemiologic Assessment
- Being tested
- MorphaBond ER, Comparator Drug
- Keywords
- Abuse, Misuse, Overdose
- Medical subject headings
- Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphaBond ERDrug
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 DrugDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| MorphaBond ER | Not described Receives: Drug: MorphaBond ER | |
| Comparator Group | Not described Receives: Drug: Comparator Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quarterly number of MorphaBond Extended Release (ER) dosage unit dispensed
Measured: October 2017 through September 2020
Percentage and rates of abuse/abuse-related outcomes of MorphaBond Extended Release (ER) vs. comparators
Measured: October 2017 through September 2020
Rates of misuse of MorphaBond Extended Release (ER) vs. comparators
Measured: October 2017 through September 2020
Rates of addiction of MorphaBond Extended Release (ER) vs. comparators
Measured: October 2017 through September 2020
Overdose rates of MorphaBond Extended Release (ER) vs. comparators
Measured: October 2017 through September 2020
Overall mortality rates and opioid overdose death rates of MorphaBond Extended Release (ER) vs. comparators
Measured: October 2017 through September 2020
Secondary outcomes (1)
Number and proportion of abuse-related outcomes by routes of administration (e.g. ingestion, inhalation, etc).
Measured: October 2017 through September 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start16 Oct 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Baseline Epidemiologic AssessmentStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 17,566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Safety Study Director, Study director, Daiichi Sankyo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033094
- Sponsor's protocol ID
- MORPH-A-U403
- Acronym
- BEAD-MB
- Status last verified
- Mar 2021
- First submitted
- 18 Jul 2019
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baseline Epidemiologic Assessment of Abuse-Deterrence of MorphaBond ER (BEAD-MB) (PMR 2961-9)
- ClinicalTrials.gov ID
- NCT04033094
- Acronym / sponsor ID
- BEAD-MB / MORPH-A-U403
- Conditions
- Baseline Epidemiologic Assessment
- Keywords
- Abuse, Misuse, Overdose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,566 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MorphaBond ER | – | Drug: MorphaBond ER |
| Comparator Group | – | Drug: Comparator Drug |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- MorphaBond ER users and relevant comparator users
Key inclusion criteria (2 listed)
- Male or female
- MorphaBond ER users or relevant comparator users
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MorphaBond ERThis 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 | MorphaBond ER |
| Comparator DrugThis 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. | Drug | Comparator Group |
Primary outcome
Quarterly number of MorphaBond Extended Release (ER) dosage unit dispensed
Time frame: October 2017 through September 2020
Percentage and rates of abuse/abuse-related outcomes of MorphaBond Extended Release (ER) vs. comparators
Time frame: October 2017 through September 2020
Rates of misuse of MorphaBond Extended Release (ER) vs. comparators
Time frame: October 2017 through September 2020
Rates of addiction of MorphaBond Extended Release (ER) vs. comparators
Time frame: October 2017 through September 2020
Overdose rates of MorphaBond Extended Release (ER) vs. comparators
Time frame: October 2017 through September 2020
Overall mortality rates and opioid overdose death rates of MorphaBond Extended Release (ER) vs. comparators
Time frame: October 2017 through September 2020
1 secondary outcome
Number and proportion of abuse-related outcomes by routes of administration (e.g. ingestion, inhalation, etc).
Time frame: October 2017 through September 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Safety Study Director study director
Daiichi Sankyo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Baseline Epidemiologic Assessment, run by Daiichi Sankyo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quarterly number of MorphaBond Extended Release (ER) dosage unit dispensed (time frame: October 2017 through September 2020). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.