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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
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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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.
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Reporting Groups
  Description
Matrifen® All patients enrolled

Baseline Measures
   Matrifen® 
Overall Participants Analyzed 
[Units: Participants]
 5308 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 70.3  (13.2) 
[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.
Gender [1] 
[Units: Participants]
 
Female   3334 
Male   1971 
[1] 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.
Type of pain [1] 
[Units: Participants]
 
Severe pain when moving   3751 
Pain caused by a tumor   1359 
Other type of pain   877 
Missing data   7 
[1] Multiple types of pain possible. One participant can have more than one type of pain.
Underlying disease [1] 
[Units: Participants]
 
Musculoskeletal disorders   3396 
Tumor   1416 
Neurological disorders   514 
Dermatological disorders   51 
Underlying disease NOS   210 
Missing data   371 
[1] 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) ]

2.  Primary:   Physician's Final Assessment of the Efficacy of Therapy With Matrifen®   [ Time Frame: After 4 week therapy with Matrifen® ]

3.  Primary:   EQ-5D (Optional): Domain Mobility   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]

4.  Primary:   EQ-5D (Optional): Domain Mobility   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]

5.  Primary:   EQ-5D (Optional): Domain Self Care   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]

6.  Primary:   EQ-5D (Optional): Domain Self Care   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]

7.  Primary:   EQ-5D (Optional): Domain Usual Activities   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]

8.  Primary:   EQ-5D (Optional): Domain Usual Activities   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]

9.  Primary:   EQ-5D (Optional): Pain / Discomfort   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]

10.  Primary:   EQ-5D (Optional): Pain / Discomfort   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]

11.  Primary:   EQ-5D (Optional): Domain Anxiety / Depression   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]

12.  Primary:   EQ-5D (Optional): Domain Anxiety / Depression   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]

13.  Primary:   EQ-5D (Optional): European Index Score   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]

14.  Primary:   EQ-5D (Optional): Visual Analogue Scale   [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]

15.  Secondary:   Physician's Assessment of the Skin Tolerability of the Fentanyl-patches   [ Time Frame: After 4 week therapy with Matrifen® ]

16.  Secondary:   Patient's Assessment of the Acceptance of the Fentanyl-patches   [ Time Frame: After 4 week therapy with Matrifen® ]

17.  Secondary:   Physician's Assessment of the Adhesion Properties of the Fentanyl-patches   [ Time Frame: After 4 week therapy with Matrifen® ]

18.  Secondary:   Physician's Final Assessment of the Tolerability of Matrifen®   [ Time Frame: After 4 week therapy with Matrifen® ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Medical Responsible
Organization: Nycomed Deutschland GmbH
phone: +49 7531 3666 0
e-mail: clinicaltrials@nycomed.com



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