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

This study has been completed.
Sponsor:
Information provided by:
Nycomed
ClinicalTrials.gov Identifier:
NCT00556270
First received: November 8, 2007
Last updated: May 4, 2012
Last verified: May 2012
  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

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 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
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, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov Identifier: NCT00556270     History of Changes
Other Study ID Numbers: Matri Matrix II 07/10
Study First Received: November 8, 2007
Last Updated: May 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 26, 2014