Matrifen® for Therapy of Severe Chronic Pain®

Study Overview
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Brief Summary
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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).

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

Conditions
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Severe Chronic Pain

Intervention / Treatment
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* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Main inclusion criteria: Outpatients with severe, chronic pain Main exclusion criteria: Hypersensitivity to fentanyl Co-administration of monoamineoxidase-inhibitors Pregnancy Respiratory depression Chronic obstructive pulmonary disease (COPD) Drug abuse Impairment of CNS functions Other criteria as defined in the Summary of Product Characteristics (Chapter 4.3)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fentanyl|Fentanyl transdermal patch. This was an observational study - therefore, the physician decided about dosage according to individual needs|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's Assessment of Pain Severity Score | Assessment on a Visual Analogue Scale from 0=No pain to 10=Most severe pain | Before and after therapy with Matrifen® (4 weeks) | 
| Physician's Final Assessment of the Efficacy of Therapy With Matrifen® | Assessment on a scale: Excellent, good, satisfactory, dissatisfactory | After 4 week therapy with Matrifen® | 
| EQ-5D (Optional): Domain Mobility | 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: I have no problems in walking around I have some problems in walking around I am confined to bed | Before and after therapy with Matrifen® (4 weeks) | 
| EQ-5D (Optional): Domain Self Care | 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: I have no problems with self-care I have some problems washing or dressing myself I am unable to wash or dress myself | Before and after therapy with Matrifen® (4 weeks) | 
| EQ-5D (Optional): Domain Usual Activities | 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: I have no problems with performing my usual activities I have some problems with performing my usual activities I am unable to perform my usual activities | Before and after therapy with Matrifen® (4 weeks) | 
| EQ-5D (Optional): Pain / Discomfort | 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: I have no pain or discomfort I have moderate pain or discomfort I have extreme pain or discomfort | Before and after therapy with Matrifen® (4 weeks) | 
| EQ-5D (Optional): Domain Anxiety / Depression | 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: I am not anxious or depressed I am moderately anxious or depressed I am extremely anxious or depressed | Before and after therapy with Matrifen® (4 weeks) | 
| EQ-5D (Optional): European Index Score | 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 | Before and after therapy with Matrifen® (4 weeks) | 
| EQ-5D (Optional): Visual Analogue Scale | Visual Analogue Scale (VAS) from 0 =worst imaginable health status, 100 =best imaginable health status | Before and after therapy with Matrifen® (4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's Assessment of the Skin Tolerability of the Fentanyl-patches | Assessment on a scale: Excellent, good, satisfactory, dissatisfactory | After 4 week therapy with Matrifen® | 
| Patient's Assessment of the Acceptance of the Fentanyl-patches | Assessment on a scale: Excellent, good, satisfactory, dissatisfactory | After 4 week therapy with Matrifen® | 
| Physician's Assessment of the Adhesion Properties of the Fentanyl-patches | Assessment on a scale: Excellent, good, satisfactory, dissatisfactory | After 4 week therapy with Matrifen® | 
| Physician's Final Assessment of the Tolerability of Matrifen® | Assessment on a scale: Excellent, good, satisfactory, dissatisfactory | After 4 week therapy with Matrifen® | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, fentanyl, transdermal patch