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

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

June 17, 2008
May 4, 2012
June 2008
July 2009   (final data collection date for primary outcome measure)
  • 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
  • Quality of life - assessment by patients (using a questionnaire) [ Time Frame: before and after therapy with Matrifen ] [ Designated as safety issue: No ]
  • Treatment success, efficacy of Matrifen [ Time Frame: within 1 month ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00699335 on ClinicalTrials.gov Archive Site
  • 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
Safety and tolerability of the Matrifen transdermal patch [ Time Frame: within 1 month ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Outpatients

Severe Chronic Pain
Drug: Fentanyl
Fentanyl transdermal patch. This was an observational study - therefore, the physician decided about dosage according to individual needs
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5308
Not Provided
July 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00699335
Matrix LQ, FT-1300-028
Not Provided
Medical Responsible, Nycomed Deutschland GmbH
Nycomed
Not Provided
Study Director: Dr. Thomas D. Bethke, MD, MBA Nycomed Deutschland GmbH, 78467 Konstanz, Germany
Nycomed
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP