The Use of QUTENZA™ in Standard Clinical Practice: a Phase IV, Multicentre, European Non-interventional Study
A detailed medical history will be taken, with particular emphasis on the primary PNP
diagnosis. In addition to all current neuropathic pain medications, all previous therapies
(pharmacological and surgical) for PNP from the point of primary diagnosis will be
QUTENZA treatments may be repeated up to every 90 days, in line with the Summary of Product
Characteristics document (SPC) as determined by the persistence or return of pain.
Patients who have not required treatment for 365 days or longer may re-enter a treatment
cycle if their treating physician decides to retreat them with QUTENZA in the course of
standard clinical management.
The duration of participation for each patient will be at least 12 months following first
Short questionnaires will be completed by the investigator whilst in contact with the
patient (either in person or by telephone) at the following time points: 1) Screening prior
to the first QUTENZA treatment; 2) at each QUTENZA treatment visit; 3) 2 weeks, 8 weeks
following the first QUTENZA treatment 4) 12 weeks following each QUTENZA treatment; 5) any
additional contact with the patient outside the protocol schedule.
For patients not returning for retreatment with QUTENZA within any of 6 months, 9 months,
and 1 year of their previous QUTENZA treatment further follow-up questionnaires will be
End of study (EoS) is defined as one year after the last patient enrolled receives their
first QUTENZA treatment.
Observational Model: Cohort, Time Perspective: Prospective
Percent change in average pain NPRS (Numeric Pain Rating Scale) scores
From Baseline to mean of all scores recorded between week 2 and week 8 following first treatment
Company Medical Expert
Astellas Pharma Europe Ltd.
Hungary: Scientific and Medical Research Council Ethics Committee