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Matrifen® for Therapy of Severe Chronic Pain® (Matrix LQ)
This study has been completed.
Sponsor:
Nycomed
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00699335
First received: June 17, 2008
Last updated: May 4, 2012
Last verified: May 2012
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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:
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) ]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® ]Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
- EQ-5D (Optional): Domain Mobility [ Time Frame: 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:
- I have no problems in walking around
- I have some problems in walking around
- I am confined to bed
- EQ-5D (Optional): Domain Self Care [ Time Frame: 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:
- I have no problems with self-care
- I have some problems washing or dressing myself
- I am unable to wash or dress myself
- EQ-5D (Optional): Domain Usual Activities [ Time Frame: 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:
- 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
- EQ-5D (Optional): Pain / Discomfort [ Time Frame: 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:
- I have no pain or discomfort
- I have moderate pain or discomfort
- I have extreme pain or discomfort
- EQ-5D (Optional): Domain Anxiety / Depression [ Time Frame: 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:
- I am not anxious or depressed
- I am moderately anxious or depressed
- I am extremely anxious or depressed
- EQ-5D (Optional): European Index Score [ Time Frame: Before and after therapy with Matrifen® (4 weeks) ]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) ]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® ]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® ]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® ]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® ]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:
-
Drug: Fentanyl
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) |
| Sexes Eligible for Study: | All |
| 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
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 |
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 20, 2017