Drug Use Study With Intuniv® in Australia

Drug Utilization Study With Intuniv® in Australia

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

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2000
      • Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants who have been prescribed Intuniv at least once during the reporting period.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
NostraData Database; All prescriptions for Intuniv available in the NostraData database in Austrialia will be analyzed in this study.
Physician Survey; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 3 years
Frequency of Weight Monitoring of Participants by Physician	Frequency of weight monitoring of participants by physician will be reported.	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.	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.	Up to 3 years

Collaborators and Investigators

• Sponsor: Shire

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 11, 2019
• Primary Completion (ACTUAL): August 27, 2021
• Study Completion (ACTUAL): August 27, 2021

Study Registration Dates

• First Submitted: April 28, 2021
• First Submitted That Met QC Criteria: April 28, 2021
• First Posted (ACTUAL): April 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: SHP503-803; EUPAS40684 (REGISTRY: EU PAS Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
• IPD Sharing Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No