Efficacy of Matrifen® in Patients Older Than 18 Years With Severe, Chronic Pain Including Quality of Life Questionnaire
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Nycomed
- 入组人数
- 5,308
- 试验地点
- 1
- 主要终点
- Patient's Assessment of Pain Severity Score
研究概览
简要总结
The aim of the study was to evaluate the efficacy and safety of Matrifen® in patients with severe and chronic pain who could only be sufficiently treated with opioid analgetics (WHO class 3).
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
- 18 Years 至 —(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
Patient's Assessment of Pain Severity Score
时间窗: Before and after therapy with Matrifen® (4 weeks)
Assessment on a Visual Analogue Scale from 0=No pain to 10=Most severe pain
Physician's Final Assessment of the Efficacy of Therapy With Matrifen®
时间窗: After 4 week therapy with Matrifen®
Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
EQ-5D (Optional): Domain Mobility
时间窗: Before and after therapy with Matrifen® (4 weeks)
This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D). Questions on a scale from 1-3 at initial and final visit: 1. I have no problems in walking around 2. I have some problems in walking around 3. I am confined to bed
EQ-5D (Optional): Domain Self Care
时间窗: Before and after therapy with Matrifen® (4 weeks)
This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D). Questions on a scale from 1-3 at initial and final visit: 1. I have no problems with self-care 2. I have some problems washing or dressing myself 3. I am unable to wash or dress myself
EQ-5D (Optional): Domain Usual Activities
时间窗: Before and after therapy with Matrifen® (4 weeks)
This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D). Questions on a scale from 1-3 at initial and final visit: 1. I have no problems with performing my usual activities 2. I have some problems with performing my usual activities 3. I am unable to perform my usual activities
EQ-5D (Optional): Pain / Discomfort
时间窗: Before and after therapy with Matrifen® (4 weeks)
This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D). Questions on a scale from 1-3 at initial and final visit: 1. I have no pain or discomfort 2. I have moderate pain or discomfort 3. I have extreme pain or discomfort
EQ-5D (Optional): Domain Anxiety / Depression
时间窗: Before and after therapy with Matrifen® (4 weeks)
This outcome measure to assess patients quality of life is based on an optional standardised patient questionnaire (EQ-5D). Questions on a scale from 1-3 at initial and final visit: 1. I am not anxious or depressed 2. I am moderately anxious or depressed 3. I am extremely anxious or depressed
EQ-5D (Optional): European Index Score
时间窗: Before and after therapy with Matrifen® (4 weeks)
Index derived from the five EQ-5D-items (= mobility, self care, usual activities, pain/discomfort, anxiety/depression) resulting in a value from -1= very ill to 1=full health
EQ-5D (Optional): Visual Analogue Scale
时间窗: Before and after therapy with Matrifen® (4 weeks)
Visual Analogue Scale (VAS) from 0 =worst imaginable health status, 100 =best imaginable health status
次要结局
- Physician's Assessment of the Skin Tolerability of the Fentanyl-patches(After 4 week therapy with Matrifen®)
- Patient's Assessment of the Acceptance of the Fentanyl-patches(After 4 week therapy with Matrifen®)
- Physician's Assessment of the Adhesion Properties of the Fentanyl-patches(After 4 week therapy with Matrifen®)
- Physician's Final Assessment of the Tolerability of Matrifen®(After 4 week therapy with Matrifen®)
