Matrifen® for Therapy of Severe Chronic Pain® | NCT00699335

Obsolete or Duplicate NCT IDs

Not provided

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fentanyl	Drug	Fentanyl transdermal patch. This was an observational study - therefore, the physician decided about dosage according to individual needs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient's Assessment of Pain Severity Score	Assessment on a Visual Analogue Scale from 0=No pain to 10=Most severe pain	Before and after therapy with Matrifen® (4 weeks)
Physician's Final Assessment of the Efficacy of Therapy With Matrifen®	Assessment on a scale: Excellent, good, satisfactory, dissatisfactory	After 4 week therapy with Matrifen®
EQ-5D (Optional): Domain Mobility	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: I have no problems in walking around I have some problems in walking around I am confined to bed	Before and after therapy with Matrifen® (4 weeks)
EQ-5D (Optional): Domain Self Care	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: I have no problems with self-care I have some problems washing or dressing myself I am unable to wash or dress myself	Before and after therapy with Matrifen® (4 weeks)
EQ-5D (Optional): Domain Usual Activities	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: I have no problems with performing my usual activities I have some problems with performing my usual activities I am unable to perform my usual activities	Before and after therapy with Matrifen® (4 weeks)
EQ-5D (Optional): Pain / Discomfort

Secondary Outcomes

Measure	Description	Time Frame
Physician's Assessment of the Skin Tolerability of the Fentanyl-patches	Assessment on a scale: Excellent, good, satisfactory, dissatisfactory	After 4 week therapy with Matrifen®
Patient's Assessment of the Acceptance of the Fentanyl-patches

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Dr. Thomas D. Bethke, MD, MBA	Nycomed Deutschland GmbH, 78467 Konstanz, Germany	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Nycomed Deutschland GmbH		Aalen		73430	Germany
Nycomed Deutschland GmbH

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Matrifen®	All patients enrolled

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

No data available

No data is available for this block.

Assessment on a scale: Excellent, good, satisfactory, dissatisfactory

Type of Units Analyzed

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age Continuous

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.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00070.3± 13.2

Gender

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.

Number

participants

Title

Denominators

Categories

Female

Title	Measurements
	BG0003334

Male

Title	Measurements
	BG000

Type of pain

Multiple types of pain possible. One participant can have more than one type of pain.

Number

participants

Title

Denominators

Categories

Severe pain when moving

Title	Measurements
	BG0003751

Pain caused by a tumor

Title	Measurements
	BG000

Underlying disease

Multiple diseases possible. One participant can have more than one underlying disease.

Number

Participants

Title

Denominators

Categories

Musculoskeletal disorders

Title	Measurements
	BG0003396

Tumor

Title	Measurements
	BG000

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Patient's Assessment of Pain Severity Score

Assessment on a Visual Analogue Scale from 0=No pain to 10=Most severe pain

Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Posted

Mean

Standard Deviation

Units on a scale

Before and after therapy with Matrifen® (4 weeks)

ID	Title	Description
OG000	Matrifen®	All patients with valid values at first and last visit

Units	Counts
Participants	OG0005226

Title

Denominators

Categories

Start of therapy

Title	Measurements
	OG0007.12± 1.52

End of study

Title	Measurements
	OG0003.32± 1.66

Primary

Physician's Final Assessment of the Efficacy of Therapy With Matrifen®

Assessment on a scale: Excellent, good, satisfactory, dissatisfactory

All patients included and treated, intention to treat, missing values not imputed

Posted

Number

Participants

After 4 week therapy with Matrifen®

ID	Title	Description
OG000	Matrifen®	All patients with valid values ('as observed')

Units	Counts
Participants	OG0005308

Primary

EQ-5D (Optional): Domain Mobility

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:

I have no problems in walking around
I have some problems in walking around
I am confined to bed

Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Posted

Number

Participants

Before and after therapy with Matrifen® (4 weeks)

ID	Title	Description
OG000	Matrifen® / Initial Visit	All patients with valid values at first and last visit
OG001	Matrifen® / Final Visit	All patients with valid values at first and last visit

Units	Counts
Participants	OG000

Primary

EQ-5D (Optional): Domain Mobility

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:

I have no problems in walking around
I have some problems in walking around
I am confined to bed

Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Posted

Mean

Standard Deviation

Units on a scale

Before and after therapy with Matrifen® (4 weeks)

ID	Title	Description
OG000	Matrifen® / Initial Visit	All patients with valid values at first and last visit
OG001	Matrifen® / Final Visit	All patients with valid values at first and last visit

Units	Counts
Participants	OG000

Primary

EQ-5D (Optional): Domain Self Care

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:

I have no problems with self-care
I have some problems washing or dressing myself
I am unable to wash or dress myself

Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Posted

Number

Participants

Before and after therapy with Matrifen® (4 weeks)

ID	Title	Description
OG000	Matrifen® / Initial Visit	All patients with valid values at first and last visit
OG001	Matrifen® / Final Visit	All patients with valid values at first and last visit

Units	Counts
Participants	OG000

Primary

EQ-5D (Optional): Domain Self Care

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:

I have no problems with self-care
I have some problems washing or dressing myself
I am unable to wash or dress myself

Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Posted

Mean

Standard Deviation

Units on a scale

Before and after therapy with Matrifen® (4 weeks)

ID	Title	Description
OG000	Matrifen® / Initial Visit	All patients with valid values at first and last visit
OG001	Matrifen® / Final Visit	All patients with valid values at first and last visit

Units	Counts
Participants	OG000

Primary

EQ-5D (Optional): Domain Usual Activities

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:

I have no problems with performing my usual activities
I have some problems with performing my usual activities
I am unable to perform my usual activities

Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Posted

Number

Participants

Before and after therapy with Matrifen® (4 weeks)

ID	Title	Description
OG000	Matrifen® / Initial Visit	All patients with valid values at first and last visit
OG001	Matrifen® / Final Visit	All patients with valid values at first and last visit

Units	Counts
Participants	OG000

Primary

EQ-5D (Optional): Domain Usual Activities

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:

I have no problems with performing my usual activities
I have some problems with performing my usual activities
I am unable to perform my usual activities

Posted

Mean

Standard Deviation

Units on a scale

Before and after therapy with Matrifen® (4 weeks)

ID	Title	Description
OG000	Matrifen® / Initial Visit	All patients with valid values at first and last visit
OG001	Matrifen® / Final Visit	All patients with valid values at first and last visit

Units	Counts
Participants	OG000

Primary

EQ-5D (Optional): Pain / Discomfort

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:

I have no pain or discomfort
I have moderate pain or discomfort
I have extreme pain or discomfort

Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Posted

Number

Participants

Before and after therapy with Matrifen® (4 weeks)

ID	Title	Description
OG000	Matrifen® / Initial Visit	All patients with valid values at first and last visit
OG001	Matrifen® / Final Visit	All patients with valid values at first and last visit

Units	Counts
Participants	OG000

Primary

EQ-5D (Optional): Pain / Discomfort

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:

I have no pain or discomfort
I have moderate pain or discomfort
I have extreme pain or discomfort

Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Posted

Mean

Standard Deviation

Units on a scale

Before and after therapy with Matrifen® (4 weeks)

ID	Title	Description
OG000	Matrifen® / Initial Visit	All patients with valid values at first and last visit
OG001	Matrifen® / Final Visit	All patients with valid values at first and last visit

Units	Counts
Participants	OG000

Secondary

Physician's Assessment of the Skin Tolerability of the Fentanyl-patches

Assessment on a scale: Excellent, good, satisfactory, dissatisfactory

All patients included and treated, intention to treat, missing values not imputed

Posted

Number

Participants

After 4 week therapy with Matrifen®

ID	Title	Description
OG000	Matrifen®	All patients with valid values ('as observed')

Units	Counts
Participants	OG0005308

Secondary

Patient's Assessment of the Acceptance of the Fentanyl-patches

Assessment on a scale: Excellent, good, satisfactory, dissatisfactory

All patients included and treated, intention to treat, missing values not imputed

Posted

Number

Participants

After 4 week therapy with Matrifen®

ID	Title	Description
OG000	Matrifen®	All patients with valid values ('as observed')

Units	Counts
Participants	OG0005308

Primary

EQ-5D (Optional): Domain Anxiety / Depression

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:

I am not anxious or depressed
I am moderately anxious or depressed
I am extremely anxious or depressed

Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Posted

Number

Participants

Before and after therapy with Matrifen® (4 weeks)

ID	Title	Description
OG000	Matrifen® / Initial Visit	All patients with valid values at first and last visit
OG001	Matrifen® / Final Visit	All patients with valid values at first and last visit

Units	Counts
Participants	OG000

Primary

EQ-5D (Optional): Domain Anxiety / Depression

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:

I am not anxious or depressed
I am moderately anxious or depressed
I am extremely anxious or depressed

Posted

Mean

Standard Deviation

Units on a scale

Before and after therapy with Matrifen® (4 weeks)

ID	Title	Description
OG000	Matrifen® / Initial Visit	All patients with valid values at first and last visit
OG001	Matrifen® / Final Visit	All patients with valid values at first and last visit

Units	Counts
Participants	OG000

Primary

EQ-5D (Optional): European Index Score

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

Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Posted

Mean

Standard Deviation

Units on a scale

Before and after therapy with Matrifen® (4 weeks)

ID	Title	Description
OG000	Matrifen®	All patients with valid values at first and last visit

Units	Counts
Participants	OG000

Primary

EQ-5D (Optional): Visual Analogue Scale

Visual Analogue Scale (VAS) from 0 =worst imaginable health status, 100 =best imaginable health status

Patients included and treated with valid data at first and last visit (without imputation of missing values), intention to treat

Posted

Mean

Standard Deviation

Units on a scale

Before and after therapy with Matrifen® (4 weeks)

ID	Title	Description
OG000	Matrifen®	All patients with valid values at first and last visit

Units	Counts
Participants	OG0003435

Secondary

Physician's Assessment of the Adhesion Properties of the Fentanyl-patches

Assessment on a scale: Excellent, good, satisfactory, dissatisfactory

All patients included and treated, intention to treat, missing values not imputed

Posted

Number

Participants

After 4 week therapy with Matrifen®

ID	Title	Description
OG000	Matrifen®	All patients with valid values ('as observed')

Units	Counts
Participants	OG0005308

Secondary

Physician's Final Assessment of the Tolerability of Matrifen®

Assessment on a scale: Excellent, good, satisfactory, dissatisfactory

All patients included and treated, intention to treat, missing values not imputed

Posted

Number

Participants

After 4 week therapy with Matrifen®

ID	Title	Description
OG000	Matrifen®	All patients with valid values ('as observed')

Units	Counts
Participants	OG0005308

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Matrifen®	Patients included and treated with at least one application of Matrifen®			80	5,308	0	5,308

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected5,308 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected5,308 at risk
Dizziness	Nervous system disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected5,308 at risk
Nausea	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0002 events2 affected5,308 at risk
Constipation	Gastrointestinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected5,308 at risk
Death	General disorders	MedDRA (12.1)	Systematic Assessment	EG00049 events49 affected5,308 at risk
General physical health deterioration	General disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected5,308 at risk
Metastases to liver	Hepatobiliary disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected5,308 at risk
Sepsis	Infections and infestations	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected5,308 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected5,308 at risk
Metastases to bone	Musculoskeletal and connective tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected5,308 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected5,308 at risk
Dementia Alzheimer's type	Psychiatric disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected5,308 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected5,308 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected5,308 at risk
Hospitalisation	Surgical and medical procedures	MedDRA (12.1)	Systematic Assessment	EG00014 events14 affected5,308 at risk
Surgery	Surgical and medical procedures	MedDRA (12.1)	Systematic Assessment	EG0006 events6 affected5,308 at risk
Amputation	Surgical and medical procedures	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected5,308 at risk
Prosthesis implantation	Surgical and medical procedures	MedDRA (12.1)	Systematic Assessment	EG0001 events1 affected5,308 at risk

ID	Term
D059350	Chronic Pain
D010146	Pain

ID	Term
D005283	Fentanyl

Title

Denominators

Categories

Initial visit

Title	Measurements
	OG00040.1± 22.0

Final visit

Title	Measurements
	OG00058.8± 20.4

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds