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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

Tracking Information
First Submitted Date June 17, 2008
First Posted Date June 18, 2008
Results First Submitted Date July 15, 2010
Results First Posted Date August 12, 2010
Last Update Posted Date May 8, 2012
Study Start Date June 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 16, 2010)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures
 (submitted: June 17, 2008)
  • Treatment success, efficacy of Matrifen [ Time Frame: within 1 month ]
  • Quality of life - assessment by patients (using a questionnaire) [ Time Frame: before and after therapy with Matrifen ]
Change History
Current Secondary Outcome Measures
 (submitted: August 16, 2010)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: June 17, 2008)
Safety and tolerability of the Matrifen transdermal patch [ Time Frame: within 1 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Matrifen® for Therapy of Severe Chronic Pain®
Official Title Efficacy of Matrifen® in Patients Older Than 18 Years With Severe, Chronic Pain Including Quality of Life Questionnaire
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Outpatients
Condition Severe Chronic Pain
Intervention Drug: Fentanyl
Fentanyl transdermal patch. This was an observational study - therefore, the physician decided about dosage according to individual needs
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 15, 2010)
5308
Original Estimated Enrollment
 (submitted: June 17, 2008)
7000
Study Completion Date Not Provided
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00699335
Other Study ID Numbers Matrix LQ, FT-1300-028
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Medical Responsible, Nycomed Deutschland GmbH
Study Sponsor Nycomed
Collaborators Not Provided
Investigators
Study Director: Dr. Thomas D. Bethke, MD, MBA Nycomed Deutschland GmbH, 78467 Konstanz, Germany
PRS Account Nycomed
Verification Date May 2012