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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 Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Severe Chronic Pain
Intervention Drug: Fentanyl
Enrollment 5308
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Matrifen®
Hide Arm/Group Description All patients enrolled
Period Title: Overall Study
Started 5308
Completed 5080
Not Completed 228
Reason Not Completed
Combination of multiple reasons             176
Missing data             52
Arm/Group Title Matrifen®
Hide Arm/Group Description All patients enrolled
Overall Number of Baseline Participants 5308
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5308 participants
70.3  (13.2)
[1]
Measure Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5308 participants
Female 3334
Male 1971
[1]
Measure Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5308 participants
Severe pain when moving 3751
Pain caused by a tumor 1359
Other type of pain 877
Missing data 7
[1]
Measure Description: Multiple types of pain possible. One participant can have more than one type of pain.
Underlying disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 5308 participants
Musculoskeletal disorders 3396
Tumor 1416
Neurological disorders 514
Dermatological disorders 51
Underlying disease NOS 210
Missing data 371
[1]
Measure Description: Multiple diseases possible. One participant can have more than one underlying disease.
1.Primary Outcome
Title Patient's Assessment of Pain Severity Score
Hide Description Assessment on a Visual Analogue Scale from 0=No pain to 10=Most severe pain
Time Frame Before and after therapy with Matrifen® (4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Arm/Group Title Matrifen®
Hide Arm/Group Description:
All patients with valid values at first and last visit
Overall Number of Participants Analyzed 5226
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Start of therapy 7.12  (1.52)
End of study 3.32  (1.66)
2.Primary Outcome
Title Physician's Final Assessment of the Efficacy of Therapy With Matrifen®
Hide Description Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
Time Frame After 4 week therapy with Matrifen®
Hide Outcome Measure Data
Hide Analysis Population Description
All patients included and treated, intention to treat, missing values not imputed
Arm/Group Title Matrifen®
Hide Arm/Group Description:
All patients with valid values ('as observed')
Overall Number of Participants Analyzed 5308
Measure Type: Number
Unit of Measure: Participants
Excellent 2530
Good 2273
Satisfactory 365
Dissatisfactory 73
Missing data 67
3.Primary Outcome
Title EQ-5D (Optional): Domain Mobility
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Arm/Group Title Matrifen® / Initial Visit Matrifen® / Final Visit
Hide Arm/Group Description:
All patients with valid values at first and last visit
All patients with valid values at first and last visit
Overall Number of Participants Analyzed 3435 3435
Measure Type: Number
Unit of Measure: Participants
I have no problems in walking around 284 1294
I have some problems in walking around 2779 1923
I am confined to bed 372 218
4.Primary Outcome
Title EQ-5D (Optional): Domain Mobility
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Arm/Group Title Matrifen® / Initial Visit Matrifen® / Final Visit
Hide Arm/Group Description:
All patients with valid values at first and last visit
All patients with valid values at first and last visit
Overall Number of Participants Analyzed 3435 3435
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.03  (0.44) 1.69  (0.58)
5.Primary Outcome
Title EQ-5D (Optional): Domain Self Care
Hide 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 with self-care
  2. I have some problems washing or dressing myself
  3. I am unable to wash or dress myself
Time Frame Before and after therapy with Matrifen® (4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Arm/Group Title Matrifen® / Initial Visit Matrifen® / Final Visit
Hide Arm/Group Description:
All patients with valid values at first and last visit
All patients with valid values at first and last visit
Overall Number of Participants Analyzed 3435 3435
Measure Type: Number
Unit of Measure: Participants
I have no problems with self-care 682 1709
I have some problems washing or dressing myself 2152 1461
I am unable to wash or dress myself 601 265
6.Primary Outcome
Title EQ-5D (Optional): Domain Self Care
Hide 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 with self-care
  2. I have some problems washing or dressing myself
  3. I am unable to wash or dress myself
Time Frame Before and after therapy with Matrifen® (4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Arm/Group Title Matrifen® / Initial Visit Matrifen® / Final Visit
Hide Arm/Group Description:
All patients with valid values at first and last visit
All patients with valid values at first and last visit
Overall Number of Participants Analyzed 3435 3435
Mean (Standard Deviation)
Unit of Measure: Units on a scale
1.98  (0.61) 1.58  (0.63)
7.Primary Outcome
Title EQ-5D (Optional): Domain Usual Activities
Hide 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 with performing my usual activities
  2. I have some problems with performing my usual activities
  3. I am unable to perform my usual activities
Time Frame Before and after therapy with Matrifen® (4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Arm/Group Title Matrifen® / Initial Visit Matrifen® / Final Visit
Hide Arm/Group Description:
All patients with valid values at first and last visit
All patients with valid values at first and last visit
Overall Number of Participants Analyzed 3435 3435
Measure Type: Number
Unit of Measure: Participants
I have no problems with performing my usual activi 142 1070
I have some problems with performing my usual acti 2227 1973
I am unable to perform my usual activities 1066 392
8.Primary Outcome
Title EQ-5D (Optional): Domain Usual Activities
Hide 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 with performing my usual activities
  2. I have some problems with performing my usual activities
  3. I am unable to perform my usual activities
Time Frame Before and after therapy with Matrifen® (4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Matrifen® / Initial Visit Matrifen® / Final Visit
Hide Arm/Group Description:
All patients with valid values at first and last visit
All patients with valid values at first and last visit
Overall Number of Participants Analyzed 3435 3435
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.27  (0.53) 1.80  (0.62)
9.Primary Outcome
Title EQ-5D (Optional): Pain / Discomfort
Hide 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 pain or discomfort
  2. I have moderate pain or discomfort
  3. I have extreme pain or discomfort
Time Frame Before and after therapy with Matrifen® (4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Arm/Group Title Matrifen® / Initial Visit Matrifen® / Final Visit
Hide Arm/Group Description:
All patients with valid values at first and last visit
All patients with valid values at first and last visit
Overall Number of Participants Analyzed 3435 3435
Measure Type: Number
Unit of Measure: Participants
I have no pain or discomfort 18 749
I have moderate pain or discomfort 1104 2503
I have extreme pain or discomfort 2313 183
10.Primary Outcome
Title EQ-5D (Optional): Pain / Discomfort
Hide 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 pain or discomfort
  2. I have moderate pain or discomfort
  3. I have extreme pain or discomfort
Time Frame Before and after therapy with Matrifen® (4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Arm/Group Title Matrifen® / Initial Visit Matrifen® / Final Visit
Hide Arm/Group Description:
All patients with valid values at first and last visit
All patients with valid values at first and last visit
Overall Number of Participants Analyzed 3435 3435
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.67  (0.48) 1.84  (0.49)
11.Primary Outcome
Title EQ-5D (Optional): Domain Anxiety / Depression
Hide 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 am not anxious or depressed
  2. I am moderately anxious or depressed
  3. I am extremely anxious or depressed
Time Frame Before and after therapy with Matrifen® (4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Arm/Group Title Matrifen® / Initial Visit Matrifen® / Final Visit
Hide Arm/Group Description:
All patients with valid values at first and last visit
All patients with valid values at first and last visit
Overall Number of Participants Analyzed 3435 3435
Measure Type: Number
Unit of Measure: Participants
I am not anxious or depressed 688 1920
I am moderately anxious or depressed 1949 1409
I am extremely anxious or depressed 798 106
12.Primary Outcome
Title EQ-5D (Optional): Domain Anxiety / Depression
Hide 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 am not anxious or depressed
  2. I am moderately anxious or depressed
  3. I am extremely anxious or depressed
Time Frame Before and after therapy with Matrifen® (4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Matrifen® / Initial Visit Matrifen® / Final Visit
Hide Arm/Group Description:
All patients with valid values at first and last visit
All patients with valid values at first and last visit
Overall Number of Participants Analyzed 3435 3435
Mean (Standard Deviation)
Unit of Measure: Units on a scale
2.03  (0.66) 1.47  (0.56)
13.Primary Outcome
Title EQ-5D (Optional): European Index Score
Hide Description 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
Time Frame Before and after therapy with Matrifen® (4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Arm/Group Title Matrifen®
Hide Arm/Group Description:
All patients with valid values at first and last visit
Overall Number of Participants Analyzed 3435
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Initial visit 0.078  (0.35)
Final visit 0.584  (0.31)
14.Primary Outcome
Title EQ-5D (Optional): Visual Analogue Scale
Hide Description Visual Analogue Scale (VAS) from 0 =worst imaginable health status, 100 =best imaginable health status
Time Frame Before and after therapy with Matrifen® (4 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Arm/Group Title Matrifen®
Hide Arm/Group Description:
All patients with valid values at first and last visit
Overall Number of Participants Analyzed 3435
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Initial visit 40.1  (22.0)
Final visit 58.8  (20.4)
15.Secondary Outcome
Title Physician's Assessment of the Skin Tolerability of the Fentanyl-patches
Hide Description Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
Time Frame After 4 week therapy with Matrifen®
Hide Outcome Measure Data
Hide Analysis Population Description
All patients included and treated, intention to treat, missing values not imputed
Arm/Group Title Matrifen®
Hide Arm/Group Description:
All patients with valid values ('as observed')
Overall Number of Participants Analyzed 5308
Measure Type: Number
Unit of Measure: Participants
Excellent 3403
Good 1716
Satisfactory 82
Dissatisfactory 18
Missing data 89
16.Secondary Outcome
Title Patient's Assessment of the Acceptance of the Fentanyl-patches
Hide Description Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
Time Frame After 4 week therapy with Matrifen®
Hide Outcome Measure Data
Hide Analysis Population Description
All patients included and treated, intention to treat, missing values not imputed
Arm/Group Title Matrifen®
Hide Arm/Group Description:
All patients with valid values ('as observed')
Overall Number of Participants Analyzed 5308
Measure Type: Number
Unit of Measure: Participants
Excellent 3210
Good 1725
Satisfactory 168
Dissatisfactory 101
Missing data 104
17.Secondary Outcome
Title Physician's Assessment of the Adhesion Properties of the Fentanyl-patches
Hide Description Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
Time Frame After 4 week therapy with Matrifen®
Hide Outcome Measure Data
Hide Analysis Population Description
All patients included and treated, intention to treat, missing values not imputed
Arm/Group Title Matrifen®
Hide Arm/Group Description:
All patients with valid values ('as observed')
Overall Number of Participants Analyzed 5308
Measure Type: Number
Unit of Measure: Participants
Excellent 3274
Good 1777
Satisfactory 162
Dissatisfactory 35
Missing data 60
18.Secondary Outcome
Title Physician's Final Assessment of the Tolerability of Matrifen®
Hide Description Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
Time Frame After 4 week therapy with Matrifen®
Hide Outcome Measure Data
Hide Analysis Population Description
All patients included and treated, intention to treat, missing values not imputed
Arm/Group Title Matrifen®
Hide Arm/Group Description:
All patients with valid values ('as observed')
Overall Number of Participants Analyzed 5308
Measure Type: Number
Unit of Measure: Participants
Excellent 2866
Good 2058
Satisfactory 161
Dissatisfactory 75
Missing data 148
Time Frame First until last visit (planned: 4 weeks)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Matrifen®
Hide Arm/Group Description Patients included and treated with at least one application of Matrifen®
All-Cause Mortality
Matrifen®
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Matrifen®
Affected / at Risk (%) # Events
Total   80/5308 (1.51%)    
Cardiac disorders   
Cardiac failure  1  1/5308 (0.02%)  1
Cardiovascular disorder  1  1/5308 (0.02%)  1
Gastrointestinal disorders   
Nausea  1  2/5308 (0.04%)  2
Constipation  1  1/5308 (0.02%)  1
General disorders   
Death  1  49/5308 (0.92%)  49
General physical health deterioration  1  1/5308 (0.02%)  1
Hepatobiliary disorders   
Metastases to liver  1  1/5308 (0.02%)  1
Infections and infestations   
Sepsis  1  1/5308 (0.02%)  1
Injury, poisoning and procedural complications   
Pelvic fracture  1  1/5308 (0.02%)  1
Musculoskeletal and connective tissue disorders   
Metastases to bone  1  1/5308 (0.02%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastasis  1  1/5308 (0.02%)  1
Nervous system disorders   
Dizziness  1  1/5308 (0.02%)  1
Psychiatric disorders   
Dementia Alzheimer's type  1  1/5308 (0.02%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/5308 (0.02%)  1
Skin and subcutaneous tissue disorders   
Dermatitis allergic  1  1/5308 (0.02%)  1
Surgical and medical procedures   
Hospitalisation  1  14/5308 (0.26%)  14
Surgery  1  6/5308 (0.11%)  6
Amputation  1  1/5308 (0.02%)  1
Prosthesis implantation  1  1/5308 (0.02%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Matrifen®
Affected / at Risk (%) # Events
Total   0/5308 (0.00%)    
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
Layout table for Results Point of Contact information
Name/Title: Medical Responsible
Organization: Nycomed Deutschland GmbH
Phone: +49 7531 3666 0
EMail: clinicaltrials@nycomed.com
Layout table for additonal information
Responsible Party: Medical Responsible, Nycomed Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00699335    
Other Study ID Numbers: Matrix LQ, FT-1300-028
First Submitted: June 17, 2008
First Posted: June 18, 2008
Results First Submitted: July 15, 2010
Results First Posted: August 12, 2010
Last Update Posted: May 8, 2012