ObesityDUSNCT06089824
Drug Utilisation of Mysimba/Contrave
An observational study of Obesity, run by Currax Pharmaceuticals at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obesity
- How many people
- 43,324 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Oct 2022
- 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: 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.
Who may be able to join
- 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.
Who cannot join
- All patients meeting inclusion criteria will be included in the study; no exclusion criteria will be applied.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity
- Medical subject headings
- Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic characteristics of patients initiating use of Mysimba/Contrave (Age)
Patient demographics (years of age on index date)
Measured: 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)
Patient demographics (sex [male/female] on index date)
Measured: 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)
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)
Measured: 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)
Smoking status (i.e., current or ever)
Measured: 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)
Existing comorbidities:
- Metabolic comorbidities (i.e., diabetes or dyslipidemia);
- Hypertension;
- Seizure disorder;
- Hepatic impairment;
- Central nervous system tumor
Measured: 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)
History of substance abuse/dependencies; including acute opioid withdrawal
Measured: 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)
History of the following medical conditions:
- Seizures;
- Bipolar disorder;
- Major depressive disorder (MDD);
- Anorexia nervosa;
- Bulimia;
- Prior use of naltrexone, bupropion, opioid, or MAOI
Measured: 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)
Pregnancy status.
Measured: 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)
Breastfeeding status.
Measured: 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)
Mysimba/Contrave initiation includes number of prescriptions
Measured: 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)
Mysimba/Contrave initiation includes number of treatment episodes
Measured: 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)
Mysimba/Contrave initiation includes duration between prescriptions
Measured: 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)
Height (meters) (most recent value on or before the index date)
Measured: 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)
Weight (kg) (most recent value on or before the index date)
Measured: 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)
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)
Measured: 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)
Mysimba/Contrave use includes the number and percentage of patients compliant with the SmPC.
Measured: 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)
Mysimba/Contrave use includes the number and percentage of patients non-compliant with the SmPC.
Measured: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study startSep 2014
- Primary completionOct 2022
- Study completionOct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- 43,324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Currax Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089824
- Sponsor's protocol ID
- NB-451
- Acronym
- DUS
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Utilisation and Safety Study of Mysimba in Europe and Contrave in the United States
- ClinicalTrials.gov ID
- NCT06089824
- Acronym / sponsor ID
- DUS / NB-451
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43,324 participants (actual)
- Lead sponsor
- Currax PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2014 (actual)
- Primary completion
- Oct 2022 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 18 Oct 2023 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- All patients meeting inclusion criteria will be included in the study; no exclusion criteria will be applied.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
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)
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)
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
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
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
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.
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.
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
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
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
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)
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)
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)
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.
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.
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 18 Oct 2023.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Obesity, run by Currax Pharmaceuticals 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 18 Oct 2023. 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?
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). The study lists 17 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 18 Oct 2023.