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OpenTrials
Completed

NCT Number: NCT04866030

Drug Use Study With Intuniv® in Australia

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

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Site

Sydney, New South Wales, 2000, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of Participants Based on Indication of Use of Intuniv

    Time frame: Up to 3 years

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

  2. Number of Participants with Presence/Absence of Contraindications

    Time frame: Up to 3 years

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

Secondary outcomes

  1. Number of Participants Based on Patterns of Drug Use

    Time frame: 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.

  2. Number of Participants Stratified by Prescriber Information Based on Physician Survey

    Time frame: Up to 3 years

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

  3. Frequency of Weight Monitoring of Participants by Physician

    Time frame: Up to 3 years

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

  4. Frequency of Blood Pressure Monitoring of Participants by Physician

    Time frame: Up to 3 years

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

  5. Frequency of Heart Rate Monitoring of Participants by Physician

    Time frame: Up to 3 years

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

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

Drug Utilization Study With Intuniv® in Australia

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2021
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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