An observational study in Obesity, sponsored by Currax Pharmaceuticals. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by Currax Pharmaceuticals · Observational
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.
Currax Pharmaceuticals is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Demographic characteristics of patients initiating use of Mysimba/Contrave (Age)
Patient demographics (years of age on index date)
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
Demographic characteristics of patients initiating use of Mysimba/Contrave (Sex)
Patient demographics (sex \[male/female\] on index date)
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
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)
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
Demographic characteristics of patients initiating use of Mysimba/Contrave (Smoking Status)
Smoking status (i.e., current or ever)
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
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
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
Demographic characteristics of patients initiating use of Mysimba/Contrave (Substance Abuse/Dependencies)
History of substance abuse/dependencies; including acute opioid withdrawal
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
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
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
Demographic characteristics of patients initiating use of Mysimba/Contrave (Pregnancy)
Pregnancy 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
Demographic characteristics of patients initiating use of Mysimba/Contrave (Breastfeeding)
Breastfeeding 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
Patterns of Mysimba/Contrave initiation (Rx)
Mysimba/Contrave initiation includes number of prescriptions
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
Patterns of Mysimba/Contrave initiation (Episodes)
Mysimba/Contrave initiation includes number of treatment 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
Patterns of Mysimba/Contrave initiation (Duration)
Mysimba/Contrave initiation includes duration between prescriptions
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
Baseline characteristics of patients initiating use of Mysimba/Contrave (Height)
Height (meters) (most recent value on or before the index date)
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
Baseline characteristics of patients initiating use of Mysimba/Contrave (Weight)
Weight (kg) (most recent value on or before the index date)
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
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)
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
Patterns of Mysimba/Contrave use (Compliance)
Mysimba/Contrave use includes the number and percentage of patients compliant with the SmPC.
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
Patterns of Mysimba/Contrave use (Non-compliance)
Mysimba/Contrave use includes the number and percentage of patients non-compliant with the SmPC.
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
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Currax Pharmaceuticals