DUS: Drug Utilisation of Mysimba/Contrave

• Sponsor: Currax Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT06089824
• Collaborator: (none)
• Enrollment: 43,324
• Location: 1
• Actual Duration (Months): 97
• Patients Per Site Per Month: 446.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity

Study Design

• Study Type: Observational
• Actual Enrollment: 43324 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Drug Utilisation and Safety Study of Mysimba in Europe and Contrave in the United States
• Actual Study Start Date: Sep 1, 2014
• Actual Primary Completion Date: Oct 1, 2022
• Actual Study Completion Date: Oct 1, 2022

Outcome Measures

Primary Outcome Measures

1. Demographic characteristics of patients initiating use of Mysimba/Contrave (Age) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Currax Pharmaceuticals	Nashville	Tennessee	United States	37208

Sponsors and Collaborators

• Currax Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Currax Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT06089824
• Other Study ID Numbers: NB-451
• First Posted: Oct 18, 2023
• Last Update Posted: Oct 18, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 18, 2023