Drug Utilisation of Mysimba/Contrave (DUS)

October 17, 2023 updated by: Currax Pharmaceuticals

Drug Utilisation and Safety Study of Mysimba in Europe and Contrave in the United States

This study will assess a retrospective cohort of users of Mysimba/Contrave with up to 548 days (~18 months) after initiation with treatment with Mysimba/Contrave. This study will describe Mysimba/Contrave utilisation and incidence of AESIs for users compliant and non-compliant with the SmPC.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43324

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37208
        • Currax Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Users of Mysimba/Contrave with at least 365 days of computerized records prior to first use in Denmark Finland, Norway and Sweden, and other countries (if meeting the threshold for patients and agreed upon between EMA and MAH) with sufficient uptake of Mysimba/Contrave in the respective national health systems. Additionally, U.S. data will be included.

Description

Inclusion Criteria:

  • At least one prescription of Mysimba/Contrave in his/her medical records any time during the study period (US) OR at least one dispensing of Mysimba/Contrave in his/her registry any time during the study period (Nordic);
  • At least 365 days of computerized records prior to first Mysimba/Contrave prescription or dispensing date; and3Patient is active (i.e., alive and registered/accruing data) at the time of the first Mysimba/Contrave prescription or dispensing date.

Exclusion Criteria:

- All patients meeting inclusion criteria will be included in the study; no exclusion criteria will be applied.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Demographic characteristics of patients initiating use of Mysimba/Contrave (Age)
Time Frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Patient demographics (years of age on index date)
All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Demographic characteristics of patients initiating use of Mysimba/Contrave (Sex)
Time Frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Patient demographics (sex [male/female] on index date)
All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Demographic characteristics of patients initiating use of Mysimba/Contrave (Race)
Time Frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Clinically recorded race (i.e., White, Black or African American, Asian, or other/unknown) and ethnicity (i.e., Hispanic or Latino, Non-Hispanic or Latino, or unknown)
All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Demographic characteristics of patients initiating use of Mysimba/Contrave (Smoking Status)
Time Frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Smoking status (i.e., current or ever)
All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Demographic characteristics of patients initiating use of Mysimba/Contrave (Comorbidities)
Time Frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period

Existing comorbidities:

  • Metabolic comorbidities (i.e., diabetes or dyslipidemia);
  • Hypertension;
  • Seizure disorder;
  • Hepatic impairment;
  • Central nervous system tumor
All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Demographic characteristics of patients initiating use of Mysimba/Contrave (Substance Abuse/Dependencies)
Time Frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
History of substance abuse/dependencies; including acute opioid withdrawal
All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Demographic characteristics of patients initiating use of Mysimba/Contrave (Medical Conditions)
Time Frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period

History of the following medical conditions:

  • Seizures;
  • Bipolar disorder;
  • Major depressive disorder (MDD);
  • Anorexia nervosa;
  • Bulimia;
  • Prior use of naltrexone, bupropion, opioid, or MAOI
All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Demographic characteristics of patients initiating use of Mysimba/Contrave (Pregnancy)
Time Frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Pregnancy status.
All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Demographic characteristics of patients initiating use of Mysimba/Contrave (Breastfeeding)
Time Frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Breastfeeding status.
All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Patterns of Mysimba/Contrave initiation (Rx)
Time Frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Mysimba/Contrave initiation includes number of prescriptions
All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Patterns of Mysimba/Contrave initiation (Episodes)
Time Frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Mysimba/Contrave initiation includes number of treatment episodes
All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Patterns of Mysimba/Contrave initiation (Duration)
Time Frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Mysimba/Contrave initiation includes duration between prescriptions
All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Baseline characteristics of patients initiating use of Mysimba/Contrave (Height)
Time Frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Height (meters) (most recent value on or before the index date)
All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Baseline characteristics of patients initiating use of Mysimba/Contrave (Weight)
Time Frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Weight (kg) (most recent value on or before the index date)
All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Baseline characteristics of patients initiating use of Mysimba/Contrave (BMI)
Time Frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
BMI (kg/m2) (most recent value on or before the index date) (obtained directly from data sources; BMI may be calculated if height and weight available)
All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Patterns of Mysimba/Contrave use (Compliance)
Time Frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Mysimba/Contrave use includes the number and percentage of patients compliant with the SmPC.
All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Patterns of Mysimba/Contrave use (Non-compliance)
Time Frame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Mysimba/Contrave use includes the number and percentage of patients non-compliant with the SmPC.
All available follow-up data up to 548 days after the index date will be included for each patient or end of study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Currax Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NB-451

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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