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Completed

NCT Number: NCT00699335

Matrifen® for Therapy of Severe Chronic Pain®

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).

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Key information

Conditions

Severe Chronic Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nycomed Deutschland GmbH, Aalen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fentanyl

Drug

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

Primary outcomes

  1. Patient's Assessment of Pain Severity Score

    Time frame: Before and after therapy with Matrifen® (4 weeks)

    Assessment on a Visual Analogue Scale from 0=No pain to 10=Most severe pain

  2. Physician's Final Assessment of the Efficacy of Therapy With Matrifen®

    Time frame: After 4 week therapy with Matrifen®

    Assessment on a scale: Excellent, good, satisfactory, dissatisfactory

  3. EQ-5D (Optional): Domain Mobility

    Time frame: 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:

    • I have no problems in walking around
    • I have some problems in walking around
    • I am confined to bed

  4. EQ-5D (Optional): Domain Self Care

    Time frame: 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:

    • I have no problems with self-care
    • I have some problems washing or dressing myself
    • I am unable to wash or dress myself

  5. EQ-5D (Optional): Domain Usual Activities

    Time frame: 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:

    • 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

  6. EQ-5D (Optional): Pain / Discomfort

    Time frame: 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:

    • I have no pain or discomfort
    • I have moderate pain or discomfort
    • I have extreme pain or discomfort

  7. EQ-5D (Optional): Domain Anxiety / Depression

    Time frame: 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:

    • I am not anxious or depressed
    • I am moderately anxious or depressed
    • I am extremely anxious or depressed

  8. EQ-5D (Optional): European Index Score

    Time frame: 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

  9. EQ-5D (Optional): Visual Analogue Scale

    Time frame: Before and after therapy with Matrifen® (4 weeks)

    Visual Analogue Scale (VAS) from 0 =worst imaginable health status, 100 =best imaginable health status

Secondary outcomes

  1. Physician's Assessment of the Skin Tolerability of the Fentanyl-patches

    Time frame: After 4 week therapy with Matrifen®

    Assessment on a scale: Excellent, good, satisfactory, dissatisfactory

  2. Patient's Assessment of the Acceptance of the Fentanyl-patches

    Time frame: After 4 week therapy with Matrifen®

    Assessment on a scale: Excellent, good, satisfactory, dissatisfactory

  3. Physician's Assessment of the Adhesion Properties of the Fentanyl-patches

    Time frame: After 4 week therapy with Matrifen®

    Assessment on a scale: Excellent, good, satisfactory, dissatisfactory

  4. Physician's Final Assessment of the Tolerability of Matrifen®

    Time frame: After 4 week therapy with Matrifen®

    Assessment on a scale: Excellent, good, satisfactory, dissatisfactory

Sponsors and collaborators

Lead sponsor

Nycomed

Industry

Registry information

Official study title

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

Acronym: Matrix LQ

Important dates

Study start
2008
Primary completion
2009
First posted
Jun 18, 2008
Registry last updated
May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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