Attention Deficit Hyperactivity Disorder (ADHD)NCT04866030
Drug Use Study With Intuniv® in Australia
An observational study of Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 1 site in Australia.
Trial summary
This study will evaluate and analyze prescribing behaviors of physicians and determine whether Intuniv was correctly prescribed in Australia. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- How many people
- 100 participants
- Where
- 1 siteAustralia
- Study dates
- 11 Mar 2019to 27 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants who have been prescribed Intuniv at least once during the reporting period.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Based on Indication of Use of Intuniv
Number of Participants Based on Indication of Use of Intuniv will be assessed.
Measured: Up to 3 years
Number of Participants with Presence/Absence of Contraindications
Number of participants with presence/absence of contraindications will be assessed.
Measured: Up to 3 years
Secondary outcomes (5)
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.
Measured: 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.
Measured: Up to 3 years
Frequency of Weight Monitoring of Participants by Physician
Frequency of weight monitoring of participants by physician will be reported.
Measured: 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.
Measured: 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.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start11 Mar 2019
- Primary completion27 Aug 2021
- Study completion27 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Shire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866030
- Sponsor's protocol ID
- SHP503-803
- Other IDs
- EUPAS40684
- Status last verified
- Sep 2021
- First submitted
- 28 Apr 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Utilization Study With Intuniv® in Australia
- ClinicalTrials.gov ID
- NCT04866030
- Acronym / sponsor ID
- SHP503-803
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2019 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants who have been prescribed Intuniv at least once during the reporting period.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
5 secondary outcomes
Number of Participants Based on Patterns of Drug Use
Time frame: Up to 3 years
Number of Participants Stratified by Prescriber Information Based on Physician Survey
Time frame: Up to 3 years
Frequency of Weight Monitoring of Participants by Physician
Time frame: Up to 3 years
Frequency of Blood Pressure Monitoring of Participants by Physician
Time frame: Up to 3 years
Frequency of Heart Rate Monitoring of Participants by Physician
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Shire
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder (ADHD), run by Shire at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Based on Indication of Use of Intuniv (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.