N/A N=5,308

Matrifen® for Therapy of Severe Chronic Pain®

Severe Chronic Pain

Bottom Line

View on ClinicalTrials.gov: NCT00699335 ↗

Enrolled (actual)

5,308

Serious AEs

1.5%

Results posted

Aug 2010

Primary outcome: Primary: Patient's Assessment of Pain Severity Score — 7.12; 3.32 Units on a scale

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Fentanyl (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Nycomed
Primary completion: Jul 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Patient's Assessment of Pain Severity Score	7.12; 3.32	—
PRIMARY Physician's Final Assessment of the Efficacy of Therapy With Matrifen®	2530; 2273; 365; 73; 67	—
PRIMARY EQ-5D (Optional): Domain Mobility	2.03; 1.69	—
PRIMARY EQ-5D (Optional): Domain Self Care	1.98; 1.58	—
PRIMARY EQ-5D (Optional): Domain Usual Activities	2.27; 1.80	—
PRIMARY EQ-5D (Optional): Pain / Discomfort	2.67; 1.84	—
PRIMARY EQ-5D (Optional): Domain Anxiety / Depression	2.03; 1.47	—
PRIMARY EQ-5D (Optional): European Index Score	0.078; 0.584	—
PRIMARY EQ-5D (Optional): Visual Analogue Scale	40.1; 58.8	—
SECONDARY Physician's Assessment of the Skin Tolerability of the Fentanyl-patches	3403; 1716; 82; 18; 89	—
SECONDARY Patient's Assessment of the Acceptance of the Fentanyl-patches	3210; 1725; 168; 101; 104	—
SECONDARY Physician's Assessment of the Adhesion Properties of the Fentanyl-patches	3274; 1777; 162; 35; 60	—
SECONDARY Physician's Final Assessment of the Tolerability of Matrifen®	2866; 2058; 161; 75; 148	—

Summary

The aim of the study was to evaluate the efficacy and safety of Matrifen® in patients with severe and chronic pain who could only be sufficiently treated with opioid analgetics (WHO class 3).

Eligibility Criteria

Main inclusion criteria:

Outpatients with severe, chronic pain

Main exclusion criteria:

Hypersensitivity to fentanyl
Co-administration of monoamineoxidase-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 (Chapter 4.3)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00699335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.