Drug Utilisation of Mysimba/Contrave

NCT06089824 | Completed

• 1 other identifier: NB-451
• Study Type: observational
• Target: 43,324
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (17)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Currax Pharmaceuticals: lead

Study Sites (1)

Currax Pharmaceuticals

Nashville, Tennessee, 37208, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 18, 2023
• Study Start: September 1, 2014
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

US (1)