An Observational Post-Authorization Safety Study (PASS) of MOVENTIG® (Naloxegol) Drug Utilization in Selected European Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17,254
- 试验地点
- 1
- 主要终点
- Augmentation
研究概览
简要总结
This post-authorization observational safety study determines the characteristics of patients prescribed naloxegol at time of first prescription and treatment patterns of naloxegol in follow-up in the United Kingdom (UK), Norway, Sweden, and Germany.
详细描述
The overall research questions for this study are: 1) What are the demographic, clinical, and treatment characteristics (including dose) at baseline of patients prescribed naloxegol in real-world practice (including the use of naloxegol in non-indicated populations)? and 2) What are the treatment patterns of naloxegol utilization during follow-up?
Primary objectives:
- To describe the characteristics of patients prescribed naloxegol at time of first prescription (demographics, targeted comorbidities, targeted comedications, provider characteristics, and indication characteristics).
- To describe any of the following treatment patterns:
- Discontinuation of naloxegol (permanently during the observation period)
- Switching from naloxegol to other drug(s) potentially used by patients with opioid induced constipation (OIC)
- Prescription of other drug(s) potentially used by patients with OIC in the same period when naloxegol is prescribed (augmentation)
- Restart in the prescription of naloxegol (after temporary discontinuation or treatment holiday)
- Continuous treatment with naloxegol during the study period
- Change in dosing
Exploratory objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has at least 1 prescription of naloxegol in his/her medical record anytime during the study period.
- •The patient has at least 12 months of computerized records prior to the first prescription of naloxegol (index date)
排除标准
- •No exclusion criteria will be applied
结局指标
主要结局
Augmentation
时间窗: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Presence (yes/no) of a patient augmenting therapy with a prescription of other drug(s) potentially used by patients with OIC in the same period when naloxegol is prescribed
Restart
时间窗: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Presence (yes/no) of a patient restarting the prescription of naloxegol (after temporary discontinuation or treatment holiday)
discontinuation
时间窗: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Presence (yes/no) of a patient discontinuing naloxegol (i.e. permanently during the observation period)
Switching
时间窗: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Presence (yes/no) of a patient switching from naloxegol to other drug(s) potentially used by patients with opioid induced constipation (OIC)
Continuous Use
时间窗: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Presence (yes/no) of a patient continuously treated with naloxegol during the study period
Dose Change
时间窗: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Presence (yes/no) of a patient changing dosing of naloxegol
次要结局
未报告次要终点