Drug Use Study With Intuniv® in Australia

Shire

Status: Completed

Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

Study type: Observational

Funder types: Industry

Identifiers

NCT04866030

SHP503-803

EUPAS40684 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 2 patient groups

NostraData Database

Description:

All prescriptions for Intuniv available in the NostraData database in Austrialia will be analyzed in this study.

Physician Survey

Description:

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.