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

Nycomed

Status: Completed

Conditions: Severe, Chronic Pain

Treatments: Drug: Matrifen

Study type: Observational

Funder types: Industry

Identifiers

NCT00556270

Matri Matrix II 07/10

Details and patient eligibility

About

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).

Enrollment: 3,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

3,000 participants in 1 patient group

Matrix II

Treatment:

Drug: Matrifen