Clinical trial NCT04866030: Drug Use Study With Intuniv® in Australia
Official title: Drug Utilization Study With Intuniv® in Australia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-04-29
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have been prescribed Intuniv at least once during the reporting period.

Brief summary: This study will evaluate and analyze prescribing behaviors of physicians and determine whether Intuniv was correctly prescribed in Australia.

Detailed description: This is a drug utilization study using retrospective database analysis where study will combine data from two sources of patient-level drug utilization data for Intuniv:

i) NostraData database: longitudinal participant level prescription database ii) Physician survey: de-identified participant data provided by representative physicians in Australia

In the NostraData database, actual prescription data are collected, which allows generation of information on drug usage. However, these prescription data do not contain patient 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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Number of Participants Based on Indication of Use of Intuniv
timeFrame: Up to 3 years
measure: Number of Participants with Presence/Absence of Contraindications
timeFrame: Up to 3 years
Secondary outcomes:
measure: Number of Participants Based on Patterns of Drug Use
timeFrame: Up to 3 years
measure: Number of Participants Stratified by Prescriber Information Based on Physician Survey
timeFrame: Up to 3 years
measure: Frequency of Weight Monitoring of Participants by Physician
timeFrame: Up to 3 years
measure: Frequency of Blood Pressure Monitoring of Participants by Physician
timeFrame: Up to 3 years
measure: Frequency of Heart Rate Monitoring of Participants by Physician
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Site
state: New South Wales
Study officials:
affiliation: Shire
name: Study Director
role: STUDY_DIRECTOR
References: