Matrifen® for Therapy of Severe Chronic Pain® - Full Text View

Purpose

The aim of the study was to evaluate the efficacy and safety of Matrifen® in patients with severe and chronic pain who could only be sufficiently treated with opioid analgetics (WHO class 3).

Condition	Intervention
Severe Chronic Pain	Drug: Fentanyl


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Efficacy of Matrifen® in Patients Older Than 18 Years With Severe, Chronic Pain Including Quality of Life Questionnaire

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain

Drug Information available for: Fentanyl Fentanyl citrate

U.S. FDA Resources

Further study details as provided by Nycomed:

Primary Outcome Measures:

Patient's Assessment of Pain Severity Score [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] [ Designated as safety issue: No ]
Assessment on a Visual Analogue Scale from 0=No pain to 10=Most severe pain
Physician's Final Assessment of the Efficacy of Therapy With Matrifen® [ Time Frame: After 4 week therapy with Matrifen® ] [ Designated as safety issue: No ]
Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
EQ-5D (Optional): Domain Mobility [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] [ Designated as safety issue: No ]
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
EQ-5D (Optional): Domain Self Care [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] [ Designated as safety issue: No ]
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
EQ-5D (Optional): Domain Usual Activities [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] [ Designated as safety issue: No ]
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
EQ-5D (Optional): Pain / Discomfort [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] [ Designated as safety issue: No ]
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
EQ-5D (Optional): Domain Anxiety / Depression [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] [ Designated as safety issue: No ]
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
EQ-5D (Optional): European Index Score [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] [ Designated as safety issue: No ]
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
EQ-5D (Optional): Visual Analogue Scale [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ] [ Designated as safety issue: No ]
Visual Analogue Scale (VAS) from 0 =worst imaginable health status, 100 =best imaginable health status

Secondary Outcome Measures:

Physician's Assessment of the Skin Tolerability of the Fentanyl-patches [ Time Frame: After 4 week therapy with Matrifen® ] [ Designated as safety issue: No ]
Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
Patient's Assessment of the Acceptance of the Fentanyl-patches [ Time Frame: After 4 week therapy with Matrifen® ] [ Designated as safety issue: No ]
Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
Physician's Assessment of the Adhesion Properties of the Fentanyl-patches [ Time Frame: After 4 week therapy with Matrifen® ] [ Designated as safety issue: No ]
Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
Physician's Final Assessment of the Tolerability of Matrifen® [ Time Frame: After 4 week therapy with Matrifen® ] [ Designated as safety issue: Yes ]
Assessment on a scale: Excellent, good, satisfactory, dissatisfactory


Enrollment:	5308
Study Start Date:	June 2008
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Fentanyl transdermal patch. This was an observational study - therefore, the physician decided about dosage according to individual needs

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Outpatients

Criteria

Main inclusion criteria:

Outpatients with severe, chronic pain

Main exclusion criteria:

Hypersensitivity to fentanyl
Co-administration of monoamineoxidase-inhibitors
Pregnancy
Respiratory depression
Chronic obstructive pulmonary disease (COPD)
Drug abuse
Impairment of CNS functions
Other criteria as defined in the Summary of Product Characteristics (Chapter 4.3)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699335

Show 1238 Study Locations

Sponsors and Collaborators

Nycomed

Investigators


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

More Information


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

Keywords provided by Nycomed:


pain fentanyl transdermal patch

Additional relevant MeSH terms:


Chronic Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Fentanyl Analgesics, Opioid Narcotics Central Nervous System Depressants	Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Anesthetics

ClinicalTrials.gov processed this record on September 28, 2016

Matrifen® for Therapy of Severe Chronic Pain® (Matrix LQ)