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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
Results First Received: July 15, 2010  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Severe Chronic Pain
Intervention: Drug: Fentanyl

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Matrifen® All patients enrolled

Participant Flow:   Overall Study
    Matrifen®  
STARTED     5308  
COMPLETED     5080  
NOT COMPLETED     228  
Combination of multiple reasons                 176  
Missing data                 52  



  Baseline Characteristics
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Reporting Groups
  Description
Matrifen® All patients enrolled

Baseline Measures
    Matrifen®  
Number of Participants  
[units: participants]
 		  5308  
Age [1]
[units: years]
Mean ± Standard Deviation 		  70.3  ± 13.2  
Gender [2]
[units: participants]
 		 
Female     3334  
Male     1971  
Type of pain [3]
[units: participants]
 		 
Severe pain when moving     3751  
Pain caused by a tumor     1359  
Other type of pain     877  
Missing data     7  
Underlying disease [4]
[units: Participants]
 		 
Musculoskeletal disorders     3396  
Tumor     1416  
Neurological disorders     514  
Dermatological disorders     51  
Underlying disease NOS     210  
Missing data     371  
[1] The reported values are related to the number of 5174 subjects. This number differs from the overall number of baseline participants due to missing data for 134 subjects.
[2] The reported values are related to the number of 5305 subjects. This number differs from the overall number of baseline participants due to missing data for 3 subjects.
[3] Multiple types of pain possible. One participant can have more than one type of pain.
[4] Multiple diseases possible. One participant can have more than one underlying disease.



  Outcome Measures
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1.  Primary:   Patient's Assessment of Pain Severity Score   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]
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2.  Primary:   Physician's Final Assessment of the Efficacy of Therapy With Matrifen®   [ Time Frame: After 4 week therapy with Matrifen® ]
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3.  Primary:   EQ-5D (Optional): Domain Mobility   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]
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4.  Primary:   EQ-5D (Optional): Domain Mobility   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]
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Measure Type Primary
Measure Title EQ-5D (Optional): Domain Mobility
Measure Description

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
Time Frame Before and after therapy with Matrifen® (4 weeks)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Reporting Groups
  Description
Matrifen® / Initial Visit All patients with valid values at first and last visit
Matrifen® / Final Visit All patients with valid values at first and last visit

Measured Values
    Matrifen® / Initial Visit     Matrifen® / Final Visit  
Number of Participants Analyzed  
[units: participants]
 		  3435     3435  
EQ-5D (Optional): Domain Mobility  
[units: Units on a scale]
Mean ± Standard Deviation 		  2.03  ± 0.44     1.69  ± 0.58  

No statistical analysis provided for EQ-5D (Optional): Domain Mobility



5.  Primary:   EQ-5D (Optional): Domain Self Care   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]
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6.  Primary:   EQ-5D (Optional): Domain Self Care   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]
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7.  Primary:   EQ-5D (Optional): Domain Usual Activities   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]
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8.  Primary:   EQ-5D (Optional): Domain Usual Activities   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]
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9.  Primary:   EQ-5D (Optional): Pain / Discomfort   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]
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10.  Primary:   EQ-5D (Optional): Pain / Discomfort   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]
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11.  Primary:   EQ-5D (Optional): Domain Anxiety / Depression   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]
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12.  Primary:   EQ-5D (Optional): Domain Anxiety / Depression   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]
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13.  Primary:   EQ-5D (Optional): European Index Score   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]
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14.  Primary:   EQ-5D (Optional): Visual Analogue Scale   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]
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15.  Secondary:   Physician's Assessment of the Skin Tolerability of the Fentanyl-patches   [ Time Frame: After 4 week therapy with Matrifen® ]
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16.  Secondary:   Patient's Assessment of the Acceptance of the Fentanyl-patches   [ Time Frame: After 4 week therapy with Matrifen® ]
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17.  Secondary:   Physician's Assessment of the Adhesion Properties of the Fentanyl-patches   [ Time Frame: After 4 week therapy with Matrifen® ]
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18.  Secondary:   Physician's Final Assessment of the Tolerability of Matrifen®   [ Time Frame: After 4 week therapy with Matrifen® ]
  Show Outcome Measure 18


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Medical Responsible
Organization: Nycomed Deutschland GmbH
phone: +49 7531 3666 0
e-mail: clinicaltrials@nycomed.com


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