Drug Use Study With VYVANSE® in Australia for Binge Eating Disorder

Last updated: November 19, 2021
Sponsor: Shire
Overall Status: Completed

Phase

N/A

Condition

Binge Eating Disorder

Bulimia

Treatment

N/A

Clinical Study ID

NCT04866043
SHP489-827
EUPAS40690
  • Ages 18-55
  • All Genders

Study Summary

This study will check how and to whom Vyvanse is prescribed in Australia by retrospectively analyzing a prescription database with additional information provided by a physician survey.

Eligibility Criteria

Inclusion

Inclusion Criteria: Main prescription data analysis:

  • At least one prescription for lisdexamfetamine dimesylate recorded in the NostraDatadatabase in Australia. For all sensitivity analyses (sensitivity analysis I, II and III):

  • At least one prescription for lisdexamfetamine dimesylate recorded in the NostraDatadatabase in Australia during the defined observation period of the study. Physician survey:

  • The physician prescribed lisdexamfetamine dimesylate for indications other than ADHD inthe last 12 months for at least one participant. Participant population:

  • Physician entered data for the participant until at least question 3 (treatmentinformation (Q03); main indication).

Exclusion

Exclusion Criteria: For all sensitivity analyses (sensitivity analysis I, II and III):

  • Evidence of use for lisdexamfetamine dimesylate for treatment of ADHD, as shown byprescription records for ADHD medication other than lisdexamfetamine dimesylate at anytime.

  • Record of at least one lisdexamfetamine dimesylate prescription prior to launch oflisdexamfetamine dimesylate for BED (02/17/2018). Additional exclusion criteria for the specific sensitivity analyses: For sensitivity analysis I:

  • Prescriptions for lisdexamfetamine dimesylate issued by pediatricians or childpsychiatrists. For sensitivity analysis II:

  • Prescriptions for lisdexamfetamine dimesylate issued by all prescribers other thanpsychiatrists (example, pediatricians, general practitioner [GPs]). For sensitivity analysis III:

  • Prescriptions for lisdexamfetamine dimesylate issued by pediatricians or childpsychiatrists.

  • For participants with age available, participants with evidence for age at firstprescription below 18 years. Physician survey and participant population:

  • Physician entered ADHD as main indication for prescription of lisdexamfetamine dimesylate (treatment information [Q03]) for the participant.

Study Design

Total Participants: 150
Study Start date:
June 01, 2019
Estimated Completion Date:
October 15, 2021

Study Description

This is a drug utilization study (DUS) using cross-sectional database analysis of participants who are prescribed lisdexamfetamine dimesylate for treatment of BED. The study will combine data from two sources of patient-level drug utilization data for lisdexamfetamine dimesylate:

  • NostraData database: Longitudinal participant level prescription dispensing database

  • Physician survey: De-identified participant data provided by representative psychiatrists and other physicians expected to treat participants with BED in Australia.

In the NostraData database, actual drug dispensing data are collected, which allows for the generation of information on actual drug usage. However, these data do not contain certain participant variables, such as age and indication, needed to monitor potential off-label use. Therefore, these data must be supplemented with another data source. The physician survey will provide the data not included in the NostraData database.

The DUS will enroll approximately 150 participants.

This DUS will be conducted in Australia. The overall time for data collection in the study will be approximately 36 months after the launch date of lisdexamfetamine dimesylate.

Connect with a study center

  • Site

    Sydney, New South Wales 2000
    Australia

    Site Not Available

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