Drug Use Study With Intuniv® in Australia

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

Official title:

Drug Utilization Study With Intuniv® in Australia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04866030
• Other study ID #: SHP503-803
• Secondary ID: EUPAS40684
• Status: Completed
• Start date: March 11, 2019
• Est. completion date: August 27, 2021

Study information

• Verified date: September 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 27, 2021
• Est. primary completion date: August 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)

Locations

Country	Name	City	State
Australia	Site	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Participants with Presence/Absence of Contraindications	Number of participants with presence/absence of contraindications will be assessed.	Up to 3 years
Secondary	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
Secondary	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
Secondary	Frequency of Weight Monitoring of Participants by Physician	Frequency of weight monitoring of participants by physician will be reported.	Up to 3 years
Secondary	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
Secondary	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

External Links

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