An Observational Post-Authorization Modified Prescription-Event Monitoring Safety Study to Monitor the Safety and Utilization of Asenapine (Sycrest) in the Primary Care Setting in England
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Incidence rate of selected important identified and potential risks
研究概览
简要总结
This post-marketing Modified Prescription-Event Monitoring (M-PEM) safety study of asenapine (SYCREST®) is to be carried out by the Drug Safety Research Unit (DSRU) as part of the Risk Management Plan required by the Committee for Medicinal Products for Human Use (CHMP) to further investigate the safety profile of asenapine in clinical practice. The aim of this study is to proactively capture safety and drug utilisation data in the post-marketing phase of license approval of asenapine as prescribed to patients by general practitioners (GPs) in England. This data is obtained through the completion of questionnaires by GPs.
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
- •Patients prescribed asenapine for any indication by NHS GPs in England.
- •Patients for whom a study questionnaire containing useful information has been returned, will be included in the study cohort regardless of the dose or frequency of administration of asenapine, and irrespective of whether any medicines are concurrently administered.
排除标准
- •patient no longer registered with the practice
- •patient for whom no information is provided on study questionnaire
- •patients for whom information provided on study questionnaire relates to another antipsychotic drug
- •patients for whom the index date is an improbable date (i.e. before market launch date)
- •patients for whom the GP reports that the patient did not take or was never prescribed asenapine
结局指标
主要结局
Incidence rate of selected important identified and potential risks
时间窗: At least 3 months after drug is first prescribed.
Incidence rates of these risks will be quantified: * Somnolence and sedation * Weight gain * Oral hypoaesthesia * Swelling of the tongue and throat * Allergic reactions (Type 1 hypersensitivity)
次要结局
未报告次要终点
研究者
Professor Saad Shakir
Director
Drug Safety Research Unit, Southampton, UK