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Efficacy of Matrifen in Patients Older Than 18 Years With Severe, Chronic Pain (MATRIX II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00556270
Recruitment Status : Completed
First Posted : November 9, 2007
Last Update Posted : May 7, 2012
Sponsor:
Information provided by:
Nycomed

Brief Summary:
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 analgesics (WHO class 3).

Condition or disease Intervention/treatment
Severe, Chronic Pain Drug: Matrifen

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Matrifen for Therapy of Severe, Chronic Pain.
Study Start Date : November 2007
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Group/Cohort Intervention/treatment
Matrix II Drug: Matrifen
as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.2)



Primary Outcome Measures :
  1. Treatment success, efficacy of Matrifen [ Time Frame: within 1 month ]

Secondary Outcome Measures :
  1. Safety and tolerability of fentanyl and the transdermal system, quality of life [ Time Frame: within 1 month ]


Information from the National Library of Medicine

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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:

  • Patients with severe, chronic pain

Main exclusion criteria:

  • Hypersensitivity of fentanyl
  • Co-administration of monoaminooxidase-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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00556270


  Show 815 Study Locations
Sponsors and Collaborators
Nycomed
Investigators
Study Director: Dr. Thomas D. Bethke, PhD, MD Nycomed Deutschland GmbH, 78467 Konstanz, Germany

ClinicalTrials.gov Identifier: NCT00556270     History of Changes
Other Study ID Numbers: Matri Matrix II 07/10
First Posted: November 9, 2007    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 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