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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00699335
Recruitment Status : Completed
First Posted : June 18, 2008
Results First Posted : August 12, 2010
Last Update Posted : May 8, 2012
Sponsor:
Information provided by:
Nycomed

Study Description
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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).

Condition or disease Intervention/treatment
Severe Chronic Pain Drug: Fentanyl

Study Design
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Study Type : Observational
Actual Enrollment : 5308 participants
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
Study Start Date : June 2008
Actual Primary Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Groups and Cohorts
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Intervention Details:
  • Drug: Fentanyl
    Fentanyl transdermal patch. This was an observational study - therefore, the physician decided about dosage according to individual needs

Outcome Measures
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Primary Outcome Measures :
  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:

    1. I have no problems in walking around
    2. I have some problems in walking around
    3. 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:

    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

  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:

    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

  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:

    1. I have no pain or discomfort
    2. I have moderate pain or discomfort
    3. 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:

    1. I am not anxious or depressed
    2. I am moderately anxious or depressed
    3. 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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699335


Locations
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Sponsors and Collaborators
Nycomed
Investigators
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Study Director: Dr. Thomas D. Bethke, MD, MBA Nycomed Deutschland GmbH, 78467 Konstanz, Germany
More Information
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Responsible Party: Medical Responsible, Nycomed Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00699335    
Other Study ID Numbers: Matrix LQ, FT-1300-028
First Posted: June 18, 2008    Key Record Dates
Results First Posted: August 12, 2010
Last Update Posted: May 8, 2012
Last Verified: May 2012
Keywords provided by Nycomed:
pain
fentanyl
transdermal patch
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics