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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:
Information provided by:
Nycomed: A Takeda Company
ClinicalTrials.gov Identifier:
NCT00556270
First received: November 8, 2007
Last updated: May 4, 2012
Last verified: May 2012
History of Changes
  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:

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

Further study details as provided by Nycomed: A Takeda Company:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556270

  Show 815 Study Locations
Sponsors and Collaborators
Nycomed: A Takeda Company
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: A Takeda Company:
pain
fentanyl
transdermal patch

Additional relevant MeSH terms:
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 23, 2013