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临床试验/NCT00699335
NCT00699335已完成不适用

Efficacy of Matrifen® in Patients Older Than 18 Years With Severe, Chronic Pain Including Quality of Life Questionnaire

Nycomed1 个研究点 分布在 1 个国家目标入组 5,308 人开始时间: 2008年6月最近更新:
适应症
相关药物

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

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®)

研究者

发起方
Nycomed
申办方类型
Industry

研究点 (1)

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