Matrifen® for Therapy of Severe Chronic Pain®

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00699335

Acronym

Matrix LQ

Enrollment

5308

Registered

2008-06-18

Start date

2008-06-30

Completion date

Unknown

Last updated

2012-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Chronic Pain

Keywords

pain, fentanyl, transdermal patch

Brief summary

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).

Interventions

DRUGFentanyl

Fentanyl transdermal patch. This was an observational study - therefore, the physician decided about dosage according to individual needs

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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)

Design outcomes

Primary

Measure	Time frame	Description
EQ-5D (Optional): Visual Analogue Scale	Before and after therapy with Matrifen® (4 weeks)	Visual Analogue Scale (VAS) from 0 =worst imaginable health status, 100 =best imaginable health status
EQ-5D (Optional): Domain Usual Activities	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	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	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	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
Patient's Assessment of Pain Severity Score	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®	After 4 week therapy with Matrifen®	Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
EQ-5D (Optional): Domain Mobility	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	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

Secondary

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

Countries

Germany

Participant flow

Participants by arm

Arm	Count
Matrifen® All patients enrolled	5,308
Total	5,308

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Combination of multiple reasons	176
Overall Study	Missing data	52

Baseline characteristics

Characteristic	Matrifen®
Age Continuous	70.3 years STANDARD_DEVIATION 13.2
Gender Female	3334 participants
Gender Male	1971 participants
Type of pain Missing data	7 participants
Type of pain Other type of pain	877 participants
Type of pain Pain caused by a tumor	1359 participants
Type of pain Severe pain when moving	3751 participants
Underlying disease Dermatological disorders	51 Participants
Underlying disease Missing data	371 Participants
Underlying disease Musculoskeletal disorders	3396 Participants
Underlying disease Neurological disorders	514 Participants
Underlying disease Tumor	1416 Participants
Underlying disease Underlying disease NOS	210 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 5,308
serious Total, serious adverse events	80 / 5,308

Outcome results

Primary

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