NCT04866030

Drug Use Study With Intuniv® in Australia

Drug Utilization Study With Intuniv® in Australia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Attention Deficit Hyperactivity Disorder (ADHD)

Timeline

• Start date: 2019-03-11
• Primary completion: 2021-08-27
• Completion: 2021-08-27
• First posted: 2021-04-29
• Last updated: 2021-10-04

Locations

1 site across 1 country: Australia