Drug Use Study With Intuniv® in Australia

Shire100 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (1)

Site

Sydney, New South Wales, Australia

Outcomes

Primary Outcomes

Number of Participants Based on Indication of Use of Intuniv

Number of Participants Based on Indication of Use of Intuniv will be assessed.

Time frame: Up to 3 years

Number of Participants with Presence/Absence of Contraindications

Number of participants with presence/absence of contraindications will be assessed.

Time frame: Up to 3 years

Secondary Outcomes

Number of Participants Based on Patterns of Drug Use

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.

Time frame: Up to 3 years

Number of Participants Stratified by Prescriber Information Based on Physician Survey

Participants will be stratified based on prescriber information which include specialty, graduation year, gender, location, and region.

Time frame: Up to 3 years

Frequency of Weight Monitoring of Participants by Physician

Frequency of weight monitoring of participants by physician will be reported.

Time frame: Up to 3 years

Frequency of Blood Pressure Monitoring of Participants by Physician

Frequency of blood pressure monitoring of participants by physician will be reported.

Time frame: Up to 3 years

Frequency of Heart Rate Monitoring of Participants by Physician

Frequency of heart rate monitoring of participants by physician will be reported.

Data from ClinicalTrials.gov

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