Trial Outcomes & Findings for Matrifen® for Therapy of Severe Chronic Pain® (NCT NCT00699335)
NCT ID: NCT00699335
Last Updated: 2012-05-08
Results Overview
Assessment on a Visual Analogue Scale from 0=No pain to 10=Most severe pain
COMPLETED
5308 participants
Before and after therapy with Matrifen® (4 weeks)
2012-05-08
Participant Flow
Participant milestones
| Measure |
Matrifen®
All patients enrolled
|
|---|---|
|
Overall Study
STARTED
|
5308
|
|
Overall Study
COMPLETED
|
5080
|
|
Overall Study
NOT COMPLETED
|
228
|
Reasons for withdrawal
| Measure |
Matrifen®
All patients enrolled
|
|---|---|
|
Overall Study
Combination of multiple reasons
|
176
|
|
Overall Study
Missing data
|
52
|
Baseline Characteristics
Matrifen® for Therapy of Severe Chronic Pain®
Baseline characteristics by cohort
| Measure |
Matrifen®
n=5308 Participants
All patients enrolled
|
|---|---|
|
Age Continuous
|
70.3 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Gender
Female
|
3334 participants
n=5 Participants
|
|
Gender
Male
|
1971 participants
n=5 Participants
|
|
Type of pain
Severe pain when moving
|
3751 participants
n=5 Participants
|
|
Type of pain
Pain caused by a tumor
|
1359 participants
n=5 Participants
|
|
Type of pain
Other type of pain
|
877 participants
n=5 Participants
|
|
Type of pain
Missing data
|
7 participants
n=5 Participants
|
|
Underlying disease
Musculoskeletal disorders
|
3396 Participants
n=5 Participants
|
|
Underlying disease
Tumor
|
1416 Participants
n=5 Participants
|
|
Underlying disease
Neurological disorders
|
514 Participants
n=5 Participants
|
|
Underlying disease
Dermatological disorders
|
51 Participants
n=5 Participants
|
|
Underlying disease
Underlying disease NOS
|
210 Participants
n=5 Participants
|
|
Underlying disease
Missing data
|
371 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before and after therapy with Matrifen® (4 weeks)Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Assessment on a Visual Analogue Scale from 0=No pain to 10=Most severe pain
Outcome measures
| Measure |
Matrifen®
n=5226 Participants
All patients with valid values at first and last visit
|
Matrifen® / Final Visit
All patients with valid values at first and last visit
|
|---|---|---|
|
Patient's Assessment of Pain Severity Score
Start of therapy
|
7.12 Units on a scale
Standard Deviation 1.52
|
—
|
|
Patient's Assessment of Pain Severity Score
End of study
|
3.32 Units on a scale
Standard Deviation 1.66
|
—
|
PRIMARY outcome
Timeframe: After 4 week therapy with Matrifen®Population: All patients included and treated, intention to treat, missing values not imputed
Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
Outcome measures
| Measure |
Matrifen®
n=5308 Participants
All patients with valid values at first and last visit
|
Matrifen® / Final Visit
All patients with valid values at first and last visit
|
|---|---|---|
|
Physician's Final Assessment of the Efficacy of Therapy With Matrifen®
Excellent
|
2530 Participants
|
—
|
|
Physician's Final Assessment of the Efficacy of Therapy With Matrifen®
Good
|
2273 Participants
|
—
|
|
Physician's Final Assessment of the Efficacy of Therapy With Matrifen®
Satisfactory
|
365 Participants
|
—
|
|
Physician's Final Assessment of the Efficacy of Therapy With Matrifen®
Dissatisfactory
|
73 Participants
|
—
|
|
Physician's Final Assessment of the Efficacy of Therapy With Matrifen®
Missing data
|
67 Participants
|
—
|
PRIMARY outcome
Timeframe: Before and after therapy with Matrifen® (4 weeks)Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
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
Outcome measures
| Measure |
Matrifen®
n=3435 Participants
All patients with valid values at first and last visit
|
Matrifen® / Final Visit
n=3435 Participants
All patients with valid values at first and last visit
|
|---|---|---|
|
EQ-5D (Optional): Domain Mobility
I have no problems in walking around
|
284 Participants
|
1294 Participants
|
|
EQ-5D (Optional): Domain Mobility
I have some problems in walking around
|
2779 Participants
|
1923 Participants
|
|
EQ-5D (Optional): Domain Mobility
I am confined to bed
|
372 Participants
|
218 Participants
|
PRIMARY outcome
Timeframe: Before and after therapy with Matrifen® (4 weeks)Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
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
Outcome measures
| Measure |
Matrifen®
n=3435 Participants
All patients with valid values at first and last visit
|
Matrifen® / Final Visit
n=3435 Participants
All patients with valid values at first and last visit
|
|---|---|---|
|
EQ-5D (Optional): Domain Mobility
|
2.03 Units on a scale
Standard Deviation 0.44
|
1.69 Units on a scale
Standard Deviation 0.58
|
PRIMARY outcome
Timeframe: Before and after therapy with Matrifen® (4 weeks)Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
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
Outcome measures
| Measure |
Matrifen®
n=3435 Participants
All patients with valid values at first and last visit
|
Matrifen® / Final Visit
n=3435 Participants
All patients with valid values at first and last visit
|
|---|---|---|
|
EQ-5D (Optional): Domain Self Care
I have no problems with self-care
|
682 Participants
|
1709 Participants
|
|
EQ-5D (Optional): Domain Self Care
I have some problems washing or dressing myself
|
2152 Participants
|
1461 Participants
|
|
EQ-5D (Optional): Domain Self Care
I am unable to wash or dress myself
|
601 Participants
|
265 Participants
|
PRIMARY outcome
Timeframe: Before and after therapy with Matrifen® (4 weeks)Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
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
Outcome measures
| Measure |
Matrifen®
n=3435 Participants
All patients with valid values at first and last visit
|
Matrifen® / Final Visit
n=3435 Participants
All patients with valid values at first and last visit
|
|---|---|---|
|
EQ-5D (Optional): Domain Self Care
|
1.98 Units on a scale
Standard Deviation 0.61
|
1.58 Units on a scale
Standard Deviation 0.63
|
PRIMARY outcome
Timeframe: Before and after therapy with Matrifen® (4 weeks)Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
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
Outcome measures
| Measure |
Matrifen®
n=3435 Participants
All patients with valid values at first and last visit
|
Matrifen® / Final Visit
n=3435 Participants
All patients with valid values at first and last visit
|
|---|---|---|
|
EQ-5D (Optional): Domain Usual Activities
I have no problems with performing my usual activi
|
142 Participants
|
1070 Participants
|
|
EQ-5D (Optional): Domain Usual Activities
I have some problems with performing my usual acti
|
2227 Participants
|
1973 Participants
|
|
EQ-5D (Optional): Domain Usual Activities
I am unable to perform my usual activities
|
1066 Participants
|
392 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Matrifen®
n=3435 Participants
All patients with valid values at first and last visit
|
Matrifen® / Final Visit
n=3435 Participants
All patients with valid values at first and last visit
|
|---|---|---|
|
EQ-5D (Optional): Domain Usual Activities
|
2.27 Units on a scale
Standard Deviation 0.53
|
1.80 Units on a scale
Standard Deviation 0.62
|
PRIMARY outcome
Timeframe: Before and after therapy with Matrifen® (4 weeks)Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
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
Outcome measures
| Measure |
Matrifen®
n=3435 Participants
All patients with valid values at first and last visit
|
Matrifen® / Final Visit
n=3435 Participants
All patients with valid values at first and last visit
|
|---|---|---|
|
EQ-5D (Optional): Pain / Discomfort
I have no pain or discomfort
|
18 Participants
|
749 Participants
|
|
EQ-5D (Optional): Pain / Discomfort
I have moderate pain or discomfort
|
1104 Participants
|
2503 Participants
|
|
EQ-5D (Optional): Pain / Discomfort
I have extreme pain or discomfort
|
2313 Participants
|
183 Participants
|
PRIMARY outcome
Timeframe: Before and after therapy with Matrifen® (4 weeks)Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
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
Outcome measures
| Measure |
Matrifen®
n=3435 Participants
All patients with valid values at first and last visit
|
Matrifen® / Final Visit
n=3435 Participants
All patients with valid values at first and last visit
|
|---|---|---|
|
EQ-5D (Optional): Pain / Discomfort
|
2.67 Units on a scale
Standard Deviation 0.48
|
1.84 Units on a scale
Standard Deviation 0.49
|
PRIMARY outcome
Timeframe: Before and after therapy with Matrifen® (4 weeks)Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
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
Outcome measures
| Measure |
Matrifen®
n=3435 Participants
All patients with valid values at first and last visit
|
Matrifen® / Final Visit
n=3435 Participants
All patients with valid values at first and last visit
|
|---|---|---|
|
EQ-5D (Optional): Domain Anxiety / Depression
I am not anxious or depressed
|
688 Participants
|
1920 Participants
|
|
EQ-5D (Optional): Domain Anxiety / Depression
I am moderately anxious or depressed
|
1949 Participants
|
1409 Participants
|
|
EQ-5D (Optional): Domain Anxiety / Depression
I am extremely anxious or depressed
|
798 Participants
|
106 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Matrifen®
n=3435 Participants
All patients with valid values at first and last visit
|
Matrifen® / Final Visit
n=3435 Participants
All patients with valid values at first and last visit
|
|---|---|---|
|
EQ-5D (Optional): Domain Anxiety / Depression
|
2.03 Units on a scale
Standard Deviation 0.66
|
1.47 Units on a scale
Standard Deviation 0.56
|
PRIMARY outcome
Timeframe: Before and after therapy with Matrifen® (4 weeks)Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
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
Outcome measures
| Measure |
Matrifen®
n=3435 Participants
All patients with valid values at first and last visit
|
Matrifen® / Final Visit
All patients with valid values at first and last visit
|
|---|---|---|
|
EQ-5D (Optional): European Index Score
Initial visit
|
0.078 Units on a scale
Standard Deviation 0.35
|
—
|
|
EQ-5D (Optional): European Index Score
Final visit
|
0.584 Units on a scale
Standard Deviation 0.31
|
—
|
PRIMARY outcome
Timeframe: Before and after therapy with Matrifen® (4 weeks)Population: Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat
Visual Analogue Scale (VAS) from 0 =worst imaginable health status, 100 =best imaginable health status
Outcome measures
| Measure |
Matrifen®
n=3435 Participants
All patients with valid values at first and last visit
|
Matrifen® / Final Visit
All patients with valid values at first and last visit
|
|---|---|---|
|
EQ-5D (Optional): Visual Analogue Scale
Initial visit
|
40.1 Units on a scale
Standard Deviation 22.0
|
—
|
|
EQ-5D (Optional): Visual Analogue Scale
Final visit
|
58.8 Units on a scale
Standard Deviation 20.4
|
—
|
SECONDARY outcome
Timeframe: After 4 week therapy with Matrifen®Population: All patients included and treated, intention to treat, missing values not imputed
Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
Outcome measures
| Measure |
Matrifen®
n=5308 Participants
All patients with valid values at first and last visit
|
Matrifen® / Final Visit
All patients with valid values at first and last visit
|
|---|---|---|
|
Physician's Assessment of the Skin Tolerability of the Fentanyl-patches
Satisfactory
|
82 Participants
|
—
|
|
Physician's Assessment of the Skin Tolerability of the Fentanyl-patches
Dissatisfactory
|
18 Participants
|
—
|
|
Physician's Assessment of the Skin Tolerability of the Fentanyl-patches
Missing data
|
89 Participants
|
—
|
|
Physician's Assessment of the Skin Tolerability of the Fentanyl-patches
Excellent
|
3403 Participants
|
—
|
|
Physician's Assessment of the Skin Tolerability of the Fentanyl-patches
Good
|
1716 Participants
|
—
|
SECONDARY outcome
Timeframe: After 4 week therapy with Matrifen®Population: All patients included and treated, intention to treat, missing values not imputed
Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
Outcome measures
| Measure |
Matrifen®
n=5308 Participants
All patients with valid values at first and last visit
|
Matrifen® / Final Visit
All patients with valid values at first and last visit
|
|---|---|---|
|
Patient's Assessment of the Acceptance of the Fentanyl-patches
Excellent
|
3210 Participants
|
—
|
|
Patient's Assessment of the Acceptance of the Fentanyl-patches
Good
|
1725 Participants
|
—
|
|
Patient's Assessment of the Acceptance of the Fentanyl-patches
Satisfactory
|
168 Participants
|
—
|
|
Patient's Assessment of the Acceptance of the Fentanyl-patches
Dissatisfactory
|
101 Participants
|
—
|
|
Patient's Assessment of the Acceptance of the Fentanyl-patches
Missing data
|
104 Participants
|
—
|
SECONDARY outcome
Timeframe: After 4 week therapy with Matrifen®Population: All patients included and treated, intention to treat, missing values not imputed
Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
Outcome measures
| Measure |
Matrifen®
n=5308 Participants
All patients with valid values at first and last visit
|
Matrifen® / Final Visit
All patients with valid values at first and last visit
|
|---|---|---|
|
Physician's Assessment of the Adhesion Properties of the Fentanyl-patches
Good
|
1777 Participants
|
—
|
|
Physician's Assessment of the Adhesion Properties of the Fentanyl-patches
Satisfactory
|
162 Participants
|
—
|
|
Physician's Assessment of the Adhesion Properties of the Fentanyl-patches
Dissatisfactory
|
35 Participants
|
—
|
|
Physician's Assessment of the Adhesion Properties of the Fentanyl-patches
Missing data
|
60 Participants
|
—
|
|
Physician's Assessment of the Adhesion Properties of the Fentanyl-patches
Excellent
|
3274 Participants
|
—
|
SECONDARY outcome
Timeframe: After 4 week therapy with Matrifen®Population: All patients included and treated, intention to treat, missing values not imputed
Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
Outcome measures
| Measure |
Matrifen®
n=5308 Participants
All patients with valid values at first and last visit
|
Matrifen® / Final Visit
All patients with valid values at first and last visit
|
|---|---|---|
|
Physician's Final Assessment of the Tolerability of Matrifen®
Excellent
|
2866 Participants
|
—
|
|
Physician's Final Assessment of the Tolerability of Matrifen®
Good
|
2058 Participants
|
—
|
|
Physician's Final Assessment of the Tolerability of Matrifen®
Satisfactory
|
161 Participants
|
—
|
|
Physician's Final Assessment of the Tolerability of Matrifen®
Dissatisfactory
|
75 Participants
|
—
|
|
Physician's Final Assessment of the Tolerability of Matrifen®
Missing data
|
148 Participants
|
—
|
Adverse Events
Matrifen®
Serious adverse events
| Measure |
Matrifen®
n=5308 participants at risk
Patients included and treated with at least one application of Matrifen®
|
|---|---|
|
Cardiac disorders
Cardiac failure
|
0.02%
1/5308 • Number of events 1 • First until last visit (planned: 4 weeks)
|
|
Cardiac disorders
Cardiovascular disorder
|
0.02%
1/5308 • Number of events 1 • First until last visit (planned: 4 weeks)
|
|
Nervous system disorders
Dizziness
|
0.02%
1/5308 • Number of events 1 • First until last visit (planned: 4 weeks)
|
|
Gastrointestinal disorders
Nausea
|
0.04%
2/5308 • Number of events 2 • First until last visit (planned: 4 weeks)
|
|
Gastrointestinal disorders
Constipation
|
0.02%
1/5308 • Number of events 1 • First until last visit (planned: 4 weeks)
|
|
General disorders
Death
|
0.92%
49/5308 • Number of events 49 • First until last visit (planned: 4 weeks)
|
|
General disorders
General physical health deterioration
|
0.02%
1/5308 • Number of events 1 • First until last visit (planned: 4 weeks)
|
|
Hepatobiliary disorders
Metastases to liver
|
0.02%
1/5308 • Number of events 1 • First until last visit (planned: 4 weeks)
|
|
Infections and infestations
Sepsis
|
0.02%
1/5308 • Number of events 1 • First until last visit (planned: 4 weeks)
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.02%
1/5308 • Number of events 1 • First until last visit (planned: 4 weeks)
|
|
Musculoskeletal and connective tissue disorders
Metastases to bone
|
0.02%
1/5308 • Number of events 1 • First until last visit (planned: 4 weeks)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.02%
1/5308 • Number of events 1 • First until last visit (planned: 4 weeks)
|
|
Psychiatric disorders
Dementia Alzheimer's type
|
0.02%
1/5308 • Number of events 1 • First until last visit (planned: 4 weeks)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.02%
1/5308 • Number of events 1 • First until last visit (planned: 4 weeks)
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.02%
1/5308 • Number of events 1 • First until last visit (planned: 4 weeks)
|
|
Surgical and medical procedures
Hospitalisation
|
0.26%
14/5308 • Number of events 14 • First until last visit (planned: 4 weeks)
|
|
Surgical and medical procedures
Surgery
|
0.11%
6/5308 • Number of events 6 • First until last visit (planned: 4 weeks)
|
|
Surgical and medical procedures
Amputation
|
0.02%
1/5308 • Number of events 1 • First until last visit (planned: 4 weeks)
|
|
Surgical and medical procedures
Prosthesis implantation
|
0.02%
1/5308 • Number of events 1 • First until last visit (planned: 4 weeks)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place