Drug Use Study With VYVANSE® in Australia for Binge Eating Disorder
NCT ID: NCT04866043
Last Updated: 2021-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2019-06-01
2021-10-15
Brief Summary
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Detailed Description
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* 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
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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NostraData Database
All prescriptions for lisdexamfetamine dimesylate available in the NostraData database at any time in the last 12 months will be collected in Australia.
No interventions assigned to this group
Physician Survey
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
\- 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 Criteria
* 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).
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.
18 Years
55 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Shire
Locations
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Site
Sydney, New South Wales, Australia
Countries
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Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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EUPAS40690
Identifier Type: REGISTRY
Identifier Source: secondary_id
SHP489-827
Identifier Type: -
Identifier Source: org_study_id