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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/NCT04866030
Registration number
NCT04866030
Ethics application status
Date submitted
28/04/2021
Date registered
29/04/2021
Date last updated
4/10/2021
Titles & IDs
Public title
Drug Use Study With Intuniv® in Australia
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Scientific title
Drug Utilization Study With Intuniv® in Australia
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Secondary ID [1]
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EUPAS40684
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Secondary ID [2]
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SHP503-803
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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:
Attention Deficit Hyperactivity Disorder (ADHD)
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Condition category
Condition code
Mental Health
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Other mental health disorders
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Neurological
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Other neurological 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 Intuniv available in the NostraData database in Austrialia will be analyzed in this study.
Physician Survey - Physician will collect medical record data of 100 participants who have been prescribed Intuniv at least once during the study period to treat participants with ADHD.
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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 Intuniv
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Assessment method [1]
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Number of Participants Based on Indication of Use of Intuniv will be assessed.
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Timepoint [1]
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Up to 3 years
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Primary outcome [2]
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Number of Participants with Presence/Absence of Contraindications
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Assessment method [2]
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Number of participants with presence/absence of contraindications will be assessed.
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Timepoint [2]
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Up to 3 years
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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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Patterns of drug use will include daily dose, first time user, repeat user, treatment duration, treatment gaps, discontinuation of ADHD therapy and switch of therapy, co-prescriptions of ADHD medication.
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Timepoint [1]
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Up to 3 years
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Secondary outcome [2]
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Number of Participants Stratified by Prescriber Information Based on Physician Survey
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Assessment method [2]
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Participants will be stratified based on prescriber information which include specialty, graduation year, gender, location, and region.
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Timepoint [2]
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Up to 3 years
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Secondary outcome [3]
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Frequency of Weight Monitoring of Participants by Physician
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Assessment method [3]
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Frequency of weight monitoring of participants by physician will be reported.
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Timepoint [3]
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Up to 3 years
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Secondary outcome [4]
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Frequency of Blood Pressure Monitoring of Participants by Physician
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Assessment method [4]
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Frequency of blood pressure monitoring of participants by physician will be reported.
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Timepoint [4]
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Up to 3 years
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Secondary outcome [5]
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Frequency of Heart Rate Monitoring of Participants by Physician
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Assessment method [5]
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Frequency of heart rate monitoring of participants by physician will be reported.
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Timepoint [5]
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Up to 3 years
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Eligibility
Key inclusion criteria
- Is indicated for the treatment of ADHD in children and adolescents 6 to 17 years old,
as monotherapy.
- Must be used as a part of a comprehensive ADHD treatment programme, typically
including psychological, educational and social measures.
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Minimum age
6
Years
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Maximum age
17
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
- Use for participants with a diagnosis other than ADHD.
- Use for children less than 6 years of age.
- Use in adults (greater than or equal to [>=] 18 years of age)
- Prescribed overdose greater than (>) 7 milligram per day (mg/day) for participants >
12 years, or > 4 mg/ day for children lesser than or equal to (<=) 12 years.
- If monotherapy with Intuniv, no prior treatment with stimulants or atomoxetine.
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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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
11/03/2019
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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
27/08/2021
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Sample size
Target
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Accrual to date
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Final
100
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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 evaluate and analyze prescribing behaviors of physicians and determine
whether Intuniv was correctly prescribed in Australia.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04866030
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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/NCT04866030
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