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OpenTrials
Completed

NCT Number: NCT06089824

Drug Utilisation of Mysimba/Contrave

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Currax Pharmaceuticals

Nashville, Tennessee, 37208, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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
  6. 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

  7. 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
  8. 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.

  9. 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.

  10. 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

  11. 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

  12. 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

  13. 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)

  14. 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)

  15. 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)

  16. 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.

  17. 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.

Sponsors and collaborators

Lead sponsor

Currax Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: DUS

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Oct 18, 2023
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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