NCT04866043

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Binge-eating Disorder

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-10-15
• Completion: 2021-10-15
• First posted: 2021-04-29
• Last updated: 2021-11-22

Locations

1 site across 1 country: Australia