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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04866043
Registration number
NCT04866043
Ethics application status
Date submitted
28/04/2021
Date registered
29/04/2021
Date last updated
22/11/2021
Titles & IDs
Public title
Drug Use Study With VYVANSE® in Australia for Binge Eating Disorder
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Scientific title
Drug Utilization Study With VYVANSE® in Australia for Binge Eating Disorder
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Secondary ID [1]
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EUPAS40690
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Secondary ID [2]
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SHP489-827
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Binge-eating Disorder
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Condition category
Condition code
Mental Health
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Eating disorders
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Diet and Nutrition
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Other diet and nutrition disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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.
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.
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Based on Indication of Use of Lisdexamfetamine Dimesylate
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Assessment method [1]
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Number of participants based on indication of use of Lisdexamfetamine Dimesylate will be assessed.
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Timepoint [1]
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Up to 36 months
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Secondary outcome [1]
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Number of Participants Based on Patterns of Drug Use
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Assessment method [1]
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Number of participants based on patterns of drug use will be assessed.
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Timepoint [1]
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Up to 36 months
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Secondary outcome [2]
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Number of Participants Based on Average Daily Dose
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Assessment method [2]
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Number of participants based on average daily dose will be assessed.
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Timepoint [2]
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Up to 36 months
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Secondary outcome [3]
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Number of Participants Based on Maximum Daily Dose
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Assessment method [3]
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Number of participants based on maximum daily dose will be assessed.
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Timepoint [3]
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Up to 36 months
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Secondary outcome [4]
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Number of Participants Based on Co-prescription
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 36 months
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Secondary outcome [5]
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Number of Participants Based on Co-diagnosis
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Assessment method [5]
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Number of participants based on co-diagnosis (BED and other indications except ADHD) will be assessed.
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Timepoint [5]
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Up to 36 months
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Secondary outcome [6]
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Number of Prescriptions of Lisdexamfetamine Dimesylate
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Assessment method [6]
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Number of Prescriptions of lisdexamfetamine dimesylate will be evaluated.
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Timepoint [6]
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Up to 36 months
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Secondary outcome [7]
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Treatment Duration
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Assessment method [7]
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Treatment duration will be defined as the length of time a participant remains on treatment.
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Timepoint [7]
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Up to 36 months
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Eligibility
Key inclusion criteria
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).
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose
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Duration
Cross-sectional
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
15/10/2021
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Sample size
Target
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Accrual to date
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Final
150
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Site - Sydney
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Recruitment postcode(s) [1]
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2000 - Sydney
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Shire
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04866043
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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Shire
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04866043
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