An observational study in Binge-eating Disorder, sponsored by Shire. Completed at 1 site in Australia. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2021-11-22.
Sponsored by Shire · Observational
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.
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:
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.
319 studies on the registry are indexed under Bulimia; 53 are open to participants now.
This study's enrollment of 150 is above the median of 76 across 58 observational studies indexed under Bulimia.
Browse Bulimia studies →Shire is the lead sponsor of 346 studies on the registry; 2 are open to participants now.
Of its 47 completed or terminated interventional studies of FDA-regulated products, 47 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants who have been prescribed lisdexamfetamine dimesylate at least once during the reporting period without evidence of use of lisdexamfetamine dimesylate for ADHD treatment.
Main prescription data analysis:
For all sensitivity analyses (sensitivity analysis I, II and III):
Physician survey:
Participant population:
Exclusion Criteria:
For all sensitivity analyses (sensitivity analysis I, II and III):
Additional exclusion criteria for the specific sensitivity analyses:
For sensitivity analysis I:
For sensitivity analysis II:
For sensitivity analysis III:
Physician survey and participant population:
All prescriptions for lisdexamfetamine dimesylate available in the NostraData database at any time in the last 12 months will be collected in Australia.
Physician will provide de-identified data of participants who have been prescribed lisdexamfetamine dimesylate at least once during the study period for indications other than attention deficit hyperactivity disorder (ADHD) in Australia.
Number of Participants Based on Indication of Use of Lisdexamfetamine Dimesylate
Number of participants based on indication of use of Lisdexamfetamine Dimesylate will be assessed.
Time frame: Up to 36 months
Number of Participants Based on Patterns of Drug Use
Number of participants based on patterns of drug use will be assessed.
Time frame: Up to 36 months
Number of Participants Based on Average Daily Dose
Number of participants based on average daily dose will be assessed.
Time frame: Up to 36 months
Number of Participants Based on Maximum Daily Dose
Number of participants based on maximum daily dose will be assessed.
Time frame: Up to 36 months
Number of Participants Based on Co-prescription
Number of participants based on co-prescription of lisdexamfetamine dimesylate with monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), guanfacine hydrochloride and other central nervous system (CNS) stimulants will be assessed.
Time frame: Up to 36 months
Number of Participants Based on Co-diagnosis
Number of participants based on co-diagnosis (BED and other indications except ADHD) will be assessed.
Time frame: Up to 36 months
Number of Prescriptions of Lisdexamfetamine Dimesylate
Number of Prescriptions of lisdexamfetamine dimesylate will be evaluated.
Time frame: Up to 36 months
Treatment Duration
Treatment duration will be defined as the length of time a participant remains on treatment.
Time frame: Up to 36 months
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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