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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00556270
First Posted: November 9, 2007
Last Update Posted: May 7, 2012
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.
Information provided by:
Nycomed
  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 analgesics (WHO class 3).

Condition Intervention
Severe, Chronic Pain Drug: Matrifen

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Matrifen for Therapy of Severe, Chronic Pain.

Resource links provided by NLM:


Further study details as provided by Nycomed:

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

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

Estimated Enrollment: 3000
Study Start Date: November 2007
Study Completion Date: May 2008
Groups/Cohorts Assigned Interventions
Matrix II Drug: Matrifen
as defined in the Summary of Product Characteristics (Fachinformation Chapter 4.2)

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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)
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00556270     History of Changes
Other Study ID Numbers: Matri Matrix II 07/10
First Submitted: November 8, 2007
First Posted: November 9, 2007
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