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

This study has been completed.

Sponsor:

Information provided by:

Nycomed: A Takeda Company

ClinicalTrials.gov Identifier:

NCT00699335

First received: June 17, 2008

Last updated: May 4, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 17, 2008

Last Updated Date

May 4, 2012

Start Date ^ICMJE

June 2008

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Quality of life - assessment by patients (using a questionnaire) [ Time Frame: before and after therapy with Matrifen ] [ Designated as safety issue: No ]
Treatment success, efficacy of Matrifen [ Time Frame: within 1 month ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00699335 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Safety and tolerability of the Matrifen transdermal patch [ Time Frame: within 1 month ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Matrifen® for Therapy of Severe Chronic Pain®

Official Title ^ICMJE

Efficacy of Matrifen® in Patients Older Than 18 Years With Severe, Chronic Pain Including Quality of Life Questionnaire

Brief Summary

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).

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Outpatients

Condition ^ICMJE

Severe Chronic Pain

Intervention ^ICMJE

Drug: Fentanyl

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

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

5308

Completion Date

Not Provided

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00699335

Other Study ID Numbers ^ICMJE

Matrix LQ, FT-1300-028

Has Data Monitoring Committee

Not Provided

Responsible Party

Medical Responsible, Nycomed Deutschland GmbH

Study Sponsor ^ICMJE

Nycomed: A Takeda Company

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Dr. Thomas D. Bethke, MD, MBA

Nycomed Deutschland GmbH, 78467 Konstanz, Germany

Information Provided By

Nycomed: A Takeda Company

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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