Text Size

Matrifen® for Therapy of Severe Chronic Pain® (Matrix LQ)

This study has been completed.
Sponsor:
Information provided by:
Nycomed: A Takeda Company
ClinicalTrials.gov Identifier:
NCT00699335
First received: June 17, 2008
Last updated: May 4, 2012
Last verified: May 2012
History of Changes
  Purpose

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).


Condition Intervention
Severe Chronic Pain
 Drug: Fentanyl

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of Matrifen® in Patients Older Than 18 Years With Severe, Chronic Pain Including Quality of Life Questionnaire

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nycomed: A Takeda Company:

Primary Outcome Measures:
  • Patient's Assessment of Pain Severity Score [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] [ Designated as safety issue: No ]
    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® [ Time Frame: After 4 week therapy with Matrifen® ] [ Designated as safety issue: No ]
    Assessment on a scale: Excellent, good, satisfactory, dissatisfactory

  • EQ-5D (Optional): Domain Mobility [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] [ Designated as safety issue: No ]

    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 [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] [ Designated as safety issue: No ]
    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 [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] [ Designated as safety issue: No ]
    Visual Analogue Scale (VAS) from 0 =worst imaginable health status, 100 =best imaginable health status


Secondary Outcome Measures:
  • Physician's Assessment of the Skin Tolerability of the Fentanyl-patches [ Time Frame: After 4 week therapy with Matrifen® ] [ Designated as safety issue: No ]
    Assessment on a scale: Excellent, good, satisfactory, dissatisfactory

  • Patient's Assessment of the Acceptance of the Fentanyl-patches [ Time Frame: After 4 week therapy with Matrifen® ] [ Designated as safety issue: No ]
    Assessment on a scale: Excellent, good, satisfactory, dissatisfactory

  • Physician's Assessment of the Adhesion Properties of the Fentanyl-patches [ Time Frame: After 4 week therapy with Matrifen® ] [ Designated as safety issue: No ]
    Assessment on a scale: Excellent, good, satisfactory, dissatisfactory

  • Physician's Final Assessment of the Tolerability of Matrifen® [ Time Frame: After 4 week therapy with Matrifen® ] [ Designated as safety issue: Yes ]
    Assessment on a scale: Excellent, good, satisfactory, dissatisfactory


Enrollment: 5308
Study Start Date: June 2008
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Fentanyl
    Fentanyl transdermal patch. This was an observational study - therefore, the physician decided about dosage according to individual needs
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatients

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699335

  Show 1238 Study Locations
Sponsors and Collaborators
Nycomed: A Takeda Company
Investigators
Study Director: Dr. Thomas D. Bethke, MD, MBA Nycomed Deutschland GmbH, 78467 Konstanz, Germany
  More Information

No publications provided

Responsible Party: Medical Responsible, Nycomed Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00699335     History of Changes
Other Study ID Numbers: Matrix LQ, FT-1300-028
Study First Received: June 17, 2008
Results First Received: July 15, 2010
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Nycomed: A Takeda Company:
pain
fentanyl
transdermal patch

Additional relevant MeSH terms:
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 16, 2013