Drug Use Study With Intuniv® in Australia

Completed

• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

• Registration Number: NCT04866030
• Lead Sponsor: Shire

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.

Study Timeline

• Study Start: 2019-03-11
• Study First Submitted: 2021-04-28
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-04-29
• Primary Completion: 2021-08-27
• Study Completion: 2021-08-27
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Based on Indication of Use of Intuniv	Up to 3 years	Number of Participants Based on Indication of Use of Intuniv will be assessed.
Number of Participants with Presence/Absence of Contraindications	Up to 3 years	Number of participants with presence/absence of contraindications will be assessed.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Based on Patterns of Drug Use	Up to 3 years	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.
Frequency of Heart Rate Monitoring of Participants by Physician	Up to 3 years	Frequency of heart rate monitoring of participants by physician will be reported.
Number of Participants Stratified by Prescriber Information Based on Physician Survey	Up to 3 years	Participants will be stratified based on prescriber information which include specialty, graduation year, gender, location, and region.
Frequency of Weight Monitoring of Participants by Physician	Up to 3 years	Frequency of weight monitoring of participants by physician will be reported.
Frequency of Blood Pressure Monitoring of Participants by Physician	Up to 3 years	Frequency of blood pressure monitoring of participants by physician will be reported.

Trial Locations

Locations (1)

Site; 🇦🇺 Sydney, New South Wales, Australia