The Use of QUTENZA™ in Standard Clinical Practice: a Phase IV, Multicentre, European Non-interventional Study
18 Years
N/A
Both
Peripheral Neuropathic Pain
Trial Information
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
documented.
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
QUTENZA treatment.
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
completed.
End of study (EoS) is defined as one year after the last patient enrolled receives their
first QUTENZA treatment.
Inclusion Criteria:
- 1. The investigator has decided to treat the patient with QUTENZA as part of
provision of standard care for the treatment of peripheral neuropathic pain in
non-diabetic adults either alone or in combination with other medicinal products for
pain
- 2. The patient is willing and able to comply with protocol requirements for the
duration of study participation
Exclusion Criteria:
- 1. The neuropathic painful areas are located only on the face, above the hairline of
the scalp, and/or in proximity to mucous membranes
- 2. The patient has a history of Type I or Type II diabetes mellitus
- 3. The patient has a diagnosis of any major psychiatric disorder or evidence of
cognitive impairment including dementia that, in the opinion of the investigator, may
interfere with patient's ability to complete study evaluations
- 4. The patient has received any prior treatment with QUTENZA patches, including
blinded patches administered as part of a clinical trial
- 5. The patient has hypersensitivity to capsaicin (i.e. chilli peppers or
over-the-counter [OTC] capsaicin products), any QUTENZA excipients or adhesives, or
local anesthetics
- 6. The patient has participated in any other clinical study or received an
investigational drug within 30 days prior to Screening Visit
- 7. The patient currently engages in any active substance abuse or has a history of
chronic substance abuse within 1 year prior to the Screening Visit; or any prior
chronic substance abuse (including alcoholism) likely to re-occur during the study
period as judged by the investigator
- 8. The patient, in the opinion of the investigator, is not suitable to participate in
this NIS for any reason
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Percent change in average pain NPRS (Numeric Pain Rating Scale) scores
Outcome Time Frame:
From Baseline to mean of all scores recorded between week 2 and week 8 following first treatment
Safety Issue:
No
Principal Investigator
Company Medical Expert
Investigator Role:
Study Director
Investigator Affiliation:
Astellas Pharma Europe Ltd.
Authority:
Hungary: Scientific and Medical Research Council Ethics Committee
Study ID:
QTZ-EC-0003
NCT ID:
NCT01737294
Start Date:
February 2012
Completion Date:
February 2014
Related Keywords:
- Peripheral Neuropathic Pain
- Phase IV
- Peripheral Neuropathic Pain
- QUTENZA
- Neuralgia
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