Status:
COMPLETED
Drug Use Study With VYVANSE® in Australia for Binge Eating Disorder
Lead Sponsor:
Shire
Conditions:
Binge-eating Disorder
Eligibility:
All Genders
18-55 years
Brief 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...
Eligibility Criteria
Inclusion
- Main prescription data analysis:
- \- At least one prescription for lisdexamfetamine dimesylate recorded in the NostraData database in Australia.
- For all sensitivity analyses (sensitivity analysis I, II and III):
- \- At least one prescription for lisdexamfetamine dimesylate recorded in the NostraData database in Australia during the defined observation period of the study.
- Physician survey:
- \- The physician prescribed lisdexamfetamine dimesylate for indications other than ADHD in the last 12 months for at least one participant.
- Participant population:
- \- Physician entered data for the participant until at least question 3 (treatment information (Q03); main indication).
Exclusion
- For all sensitivity analyses (sensitivity analysis I, II and III):
- Evidence of use for lisdexamfetamine dimesylate for treatment of ADHD, as shown by prescription records for ADHD medication other than lisdexamfetamine dimesylate at any time.
- Record of at least one lisdexamfetamine dimesylate prescription prior to launch of lisdexamfetamine 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 child psychiatrists.
- For sensitivity analysis II:
- \- Prescriptions for lisdexamfetamine dimesylate issued by all prescribers other than psychiatrists (example, pediatricians, general practitioner \[GPs\]).
- For sensitivity analysis III:
- Prescriptions for lisdexamfetamine dimesylate issued by pediatricians or child psychiatrists.
- For participants with age available, participants with evidence for age at first prescription 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.
Key Trial Info
Start Date :
June 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 15 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04866043
Start Date
June 1 2019
End Date
October 15 2021
Last Update
November 22 2021
Active Locations (1)
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1
Site
Sydney, New South Wales, Australia, 2000