Efficacy of Matrifen in Patients Older Than 18 Years With Severe, Chronic Pain Including Quality of Life Questionnaire - Full Text View

Efficacy of Matrifen in Patients Older Than 18 Years With Severe, Chronic Pain Including Quality of Life Questionnaire (Matrix LQ)

This study is currently recruiting participants.

Verified by Nycomed, April 2009

First Received: June 17, 2008 Last Updated: April 23, 2009 History of Changes

Sponsored by:	Nycomed
Information provided by:	Nycomed
ClinicalTrials.gov Identifier:	NCT00699335

Purpose

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

Condition
Severe, Chronic Pain

Drug Information available for: Fentanyl Fentanyl Citrate

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Efficacy of Matrifen in Patients Older Than 18 Years With Severe, Chronic Pain Including Quality of Life Questionnaire

Further study details as provided by Nycomed:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	7000
Study Start Date:	June 2008
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Eligibility

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

Study Population

Outpatients

Criteria

Main inclusion criteria:

Patients 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 (Fachinformation Chapter 4.3)

Contacts and Locations

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

Contacts

Contact: Nycomed

clinicaltrials@nycomed.com

Show 1272 Study Locations

Sponsors and Collaborators

Nycomed

Investigators

Study Director:

Dr. Thomas D. Bethke, MD, MBA

Nycomed Deutschland GmbH, 78467 Konstanz, Germany

More Information

No publications provided

Study ID Numbers:	Matrix LQ, FT-1300-028
Study First Received:	June 17, 2008
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00699335 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Nycomed:

pain
fentanyl
transdermal patch

Study placed in the following topic categories:

Fentanyl
Quality of Life
Pain

ClinicalTrials.gov processed this record on May 07, 2009