Clinical trial NCT06089824: Drug Utilisation of Mysimba/Contrave
Official title: Drug Utilisation and Safety Study of Mysimba in Europe and Contrave in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Currax Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-10-18
Enrollment: 43324
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Demographic characteristics of patients initiating use of Mysimba/Contrave (Age)
timeFrame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
measure: Demographic characteristics of patients initiating use of Mysimba/Contrave (Sex)
timeFrame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
measure: Demographic characteristics of patients initiating use of Mysimba/Contrave (Race)
timeFrame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
measure: Demographic characteristics of patients initiating use of Mysimba/Contrave (Smoking Status)
timeFrame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
measure: Demographic characteristics of patients initiating use of Mysimba/Contrave (Comorbidities)
timeFrame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
measure: Demographic characteristics of patients initiating use of Mysimba/Contrave (Substance Abuse/Dependencies)
timeFrame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
measure: Demographic characteristics of patients initiating use of Mysimba/Contrave (Medical Conditions)
timeFrame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
measure: Demographic characteristics of patients initiating use of Mysimba/Contrave (Pregnancy)
timeFrame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
measure: Demographic characteristics of patients initiating use of Mysimba/Contrave (Breastfeeding)
timeFrame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
measure: Patterns of Mysimba/Contrave initiation (Rx)
timeFrame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
measure: Patterns of Mysimba/Contrave initiation (Episodes)
timeFrame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
measure: Patterns of Mysimba/Contrave initiation (Duration)
timeFrame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
measure: Baseline characteristics of patients initiating use of Mysimba/Contrave (Height)
timeFrame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
measure: Baseline characteristics of patients initiating use of Mysimba/Contrave (Weight)
timeFrame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
measure: Baseline characteristics of patients initiating use of Mysimba/Contrave (BMI)
timeFrame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
measure: Patterns of Mysimba/Contrave use (Compliance)
timeFrame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
measure: Patterns of Mysimba/Contrave use (Non-compliance)
timeFrame: All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Currax Pharmaceuticals
state: Tennessee
Study officials:
References: