Drug Utilization Study With Intuniv® in Australia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants Based on Indication of Use of Intuniv
研究概览
简要总结
This study will evaluate and analyze prescribing behaviors of physicians and determine whether Intuniv was correctly prescribed in Australia.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Number of Participants Based on Indication of Use of Intuniv
时间窗: 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
时间窗: Up to 3 years
Number of participants with presence/absence of contraindications will be assessed.
次要结局
- Number of Participants Based on Patterns of Drug Use(Up to 3 years)
- Frequency of Heart Rate Monitoring of Participants by Physician(Up to 3 years)
- Number of Participants Stratified by Prescriber Information Based on Physician Survey(Up to 3 years)
- Frequency of Weight Monitoring of Participants by Physician(Up to 3 years)
- Frequency of Blood Pressure Monitoring of Participants by Physician(Up to 3 years)