Matrifen® for Therapy of Severe Chronic Pain®

Completed

• Conditions: Severe Chronic Pain

• Registration Number: NCT00699335
• Lead Sponsor: Nycomed

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 available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-17
• Study First Posted: 2008-06-18
• Primary Completion: 2009-07
• Results First Submitted: 2010-07-15
• Results First Submitted QC: 2010-07-15
• Results First Posted: 2010-08-12
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5308

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient's Assessment of Pain Severity Score	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®	After 4 week therapy with Matrifen®	Assessment on a scale: Excellent, good, satisfactory, dissatisfactory
EQ-5D (Optional): Domain Mobility	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 in walking around; 2. I have some problems in walking around; 3. I am confined to bed
EQ-5D (Optional): Domain Self Care	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 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	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
EQ-5D (Optional): Pain / Discomfort	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 pain or discomfort; 2. I have moderate pain or discomfort; 3. I have extreme pain or discomfort
EQ-5D (Optional): Domain Anxiety / Depression	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
EQ-5D (Optional): European Index Score	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	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

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

Trial Locations

Locations (1)

Nycomed Deutschland GmbH; 🇩🇪 Östringen, Germany