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).
Study Type
OBSERVATIONAL
Enrollment
5,308
Fentanyl transdermal patch. This was an observational study - therefore, the physician decided about dosage according to individual needs
Patient's Assessment of Pain Severity Score
Assessment on a Visual Analogue Scale from 0=No pain to 10=Most severe pain
Time frame: 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
Time frame: 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: 1. I have no problems in walking around 2. I have some problems in walking around 3. I am confined to bed
Time frame: 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: 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
Time frame: 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: 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
Time frame: 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: 1. I have no pain or discomfort 2. I have moderate pain or discomfort 3. I have extreme pain or discomfort
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Nycomed Deutschland GmbH
Aalen, Germany
Nycomed Deutschland GmbH
Abensberg, Germany
Nycomed Deutschland GmbH
Adelebsen, Germany
Nycomed Deutschland GmbH
Ahaus, Germany
Nycomed Deutschland GmbH
Ahlen, Germany
Nycomed Deutschland GmbH
Ahrensburg, Germany
Nycomed Deutschland GmbH
Albstadt, Germany
Nycomed Deutschland GmbH
Aldenhoven, Germany
Nycomed Deutschland GmbH
Alfeld, Germany
Nycomed Deutschland GmbH
Alfhausen, Germany
...and 1225 more locations
Time frame: 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: 1. I am not anxious or depressed 2. I am moderately anxious or depressed 3. I am extremely anxious or depressed
Time frame: 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
Time frame: 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
Time frame: Before and after therapy with Matrifen® (4 weeks)
Physician's Assessment of the Skin Tolerability of the Fentanyl-patches
Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
Time frame: After 4 week therapy with Matrifen®
Patient's Assessment of the Acceptance of the Fentanyl-patches
Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
Time frame: 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
Time frame: After 4 week therapy with Matrifen®
Physician's Final Assessment of the Tolerability of Matrifen®
Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
Time frame: After 4 week therapy with Matrifen®