PASCONAL NERVENTROPFEN in the Treatment of Adults and Children Suffering From Nervous Diseases (e.g. Sleep Disorders Due to Nervousness)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 325
- 试验地点
- 1
- 主要终点
- Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3
研究概览
简要总结
The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness.
详细描述
The purpose of this observational study is to give an overview of the use of PASCONAL NERVENTROPFEN in a 2-4 week treatment of nervous diseases, especially sleep disorders due to nervousness.
Efficacy and tolerability of the drug will be assessed. Special regard will be taken to the administration management, dose regimen, and to the effectiveness and safety in special patient groups (children 1-12 years of age), in relation to treatment conformity to the Summary of Product Characteristics (SmPC).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Sumscore of 12 Individual Symptoms for Visit 1 (Baseline), Visit 2, and Visit 3
时间窗: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
The severity of 12 symptoms (nervousness/restlessness, irritability/eccentricity, sleep disorders, fitful sleep, hyperactivity, nocturnal activity, lack of concentration/forgetfulness, tiredness, discontent, listlessness, gastrointestinal problems, and headache/pressure) was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints) and for the sum score of all 12 individual symptom scores (0 (no complaints) - 36 (all strong complaints).
Irritability/Eccentricity for Visit 1 (Baseline), Visit 2, Visit 3 and Last Observation
时间窗: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
The severity of irritability/eccentricity was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).
Nervousness/Restlessness for Visit 1 (Baseline), Visit 2, Visit 3 and Last Obsevation
时间窗: begin (visit 1), appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
The severity of nervousness/restlessness was graded on a four-point scale from 0 (no complaints) to 3 (strong complaints).
Tolerability After Visit 2 and Visit 3
时间窗: appr. after 2 weeks (visit 2), and appr. after 4 weeks (visit 3)
Assessment of tolerability at visit 2 and visit 3 well tolerated = no side effcts poor tolerated = side effects
次要结局
- Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Duration of Treatment(begin (visit 1) and last observation (appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)))
- Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Duration of Treatment(begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)))
- Direction of Change of Symptom Irritability/Eccentricity Between Baseline and Last Observation by Concomitant Medication(begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)))
- Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Concomitant Medication (Yes/no)(appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3))
- Efficacy Rating for PASCONAL® NERVENTROPFEN (Last Value) Compared to Previous Therapy by Treatment Duration(appr. after 2 weeks (visit 2) and appr. after 4 weeks (visit 3))
- Changes of the Sum Score Between Baseline and Last Observation by Concomitant Medication and Treatment Duration(begin (visit 1) and last obvservation (could be appr. after 2 weeks (visit 2) or 4 weeks (visit 3)))
- Direction of Change of Symptom Nervousness/Restlessnes Between Baseline and Last Observation by Concomitant Medication(begin (visit 1) and last observation (could be appr. after 2 weeks (visit 2) or appr. after 4 weeks (visit 3)))