Drug Utilisation of Mysimba/Contrave

Obesity Clinical Trial

— DUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06089824
• Other study ID #: NB-451
• Status: Completed
• Start date: September 2014
• Est. completion date: October 2022

Study information

• Verified date: October 2023
• Source: Currax Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43324
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
United States	Currax Pharmaceuticals	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Currax Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographic characteristics of patients initiating use of Mysimba/Contrave (Age)	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
Primary	Demographic characteristics of patients initiating use of Mysimba/Contrave (Sex)	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
Primary	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)	All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Primary	Demographic characteristics of patients initiating use of Mysimba/Contrave (Smoking Status)	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
Primary	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	All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Primary	Demographic characteristics of patients initiating use of Mysimba/Contrave (Substance Abuse/Dependencies)	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
Primary	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	All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Primary	Demographic characteristics of patients initiating use of Mysimba/Contrave (Pregnancy)	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
Primary	Demographic characteristics of patients initiating use of Mysimba/Contrave (Breastfeeding)	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
Primary	Patterns of Mysimba/Contrave initiation (Rx)	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
Primary	Patterns of Mysimba/Contrave initiation (Episodes)	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
Primary	Patterns of Mysimba/Contrave initiation (Duration)	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
Primary	Baseline characteristics of patients initiating use of Mysimba/Contrave (Height)	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
Primary	Baseline characteristics of patients initiating use of Mysimba/Contrave (Weight)	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
Primary	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)	All available follow-up data up to 548 days after the index date will be included for each patient or end of study period
Primary	Patterns of Mysimba/Contrave use (Compliance)	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
Primary	Patterns of Mysimba/Contrave use (Non-compliance)	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