Clinical trial NCT02171182: A Study of Efficacy and Safety of Qutenza in Patients With Post-operative Peripheral Neuropathic Pain
Official title: A Non-interventional Post-registration Clinical Study of Efficacy and Safety of Qutenza in Patients With Post-operative Peripheral Neuropathic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-operative Peripheral Neuropathic Pain
Keywords: Qutenza
8% capsaicin patch
Non-interventional
Post-operative peripheral neuropathic pain
Observational
Czech Republic
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2014-06-24
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with post-operative peripheral neuropathic pain

Brief summary: The aim of this study is to monitor the effectiveness and used dosage of the 8% capsaicin patch in real-life clinical practice in the treatment of post-operative neuropathic pain.


Eligibility criteria: Inclusion Criteria:

* diagnosed peripheral post-operative neuropathic pain

Exclusion Criteria:

* hypersensitivity to capsaicin
* pregnancy
* diabetes mellitus
* treatment of face

Primary outcomes:
measure: Percentage rate of responders
timeFrame: Baseline, Week 13
Secondary outcomes:
measure: Basic demographic parameters
timeFrame: Baseline
measure: Previous treatment of neuropathy
timeFrame: Baseline
measure: Reason for a change in the therapy
timeFrame: Baseline
measure: Dose
timeFrame: Baseline, Week 13 and Week 26
measure: Size of the area affected by neuropathic pain
timeFrame: Baseline, Week 13 and Week 26
measure: Concomitant neuropathic medication
timeFrame: Baseline, Week 13 and Week 26
measure: Efficacy of treatment
timeFrame: Baseline, Week 8, Week 13 and Week 26
measure: Quality of life questionnaire (EQ-5D)
timeFrame: Baseline, Week 8, Week 13 and Week 26
measure: Consumption of rescue analgesic medication
timeFrame: Baseline, Week 8, Week 13 and Week 26
measure: Consumption of additional medical care for neuropathic pain
timeFrame: Baseline, Week 8, Week 13 and Week 26
Other outcomes:
Locations:
city: Benešov
country: Czech Republic
facility: Site CZ42019 Hospital
city: Beroun
country: Czech Republic
facility: Site CZ42026 Hospital
city: Brno
country: Czech Republic
facility: Site CZ42008 Onco Clinic
city: Brno
country: Czech Republic
facility: Site CZ42001 Sv. Anna Hospital
city: Havlíčkův Brod
country: Czech Republic
facility: Site CZ42015 Hospital
city: Hořovice
country: Czech Republic
facility: Site CZ42029 Hospital
city: Hradec Králové
country: Czech Republic
facility: Site CZ42009 University Hospital
city: Jihlava
country: Czech Republic
facility: Site CZ42004 Hospital
city: Karlovy Vary
country: Czech Republic
facility: Site CZ42022 Hospital
city: Klatovy
country: Czech Republic
facility: Site CZ42017 Hospital
city: Krnov
country: Czech Republic
facility: Site CZ42025 Private Practice
city: Liberec
country: Czech Republic
facility: Site CZ42016 Hospital
city: Mladá Boleslav
country: Czech Republic
facility: Site CZ42023 Hospital
city: Nové Město
country: Czech Republic
facility: Site CZ42020 Hospital
city: Olomouc
country: Czech Republic
facility: Site CZ42010 University Hospital
city: Opava
country: Czech Republic
facility: Site CZ42012 Hospital
city: Ostrava
country: Czech Republic
facility: Site CZ42002 University Hospital
city: Plzeň
country: Czech Republic
facility: Site CZ42006 University Hospital
city: Prague 4
country: Czech Republic
facility: Site CZ42013 Hospital
city: Prague 4
country: Czech Republic
facility: Site CZ42018 Rheumatological Institute
city: Prague 5
country: Czech Republic
facility: Site CZ42005 University Hospital
city: Prague 6
country: Czech Republic
facility: Site CZ42021 Military Hospital
city: Semily
country: Czech Republic
facility: Site CZ42027 Hospital
city: Sokolov
country: Czech Republic
facility: Site CZ42011 Hospital
city: Teplice
country: Czech Republic
facility: Site CZ42024 Hospital
city: Uherské Hradiště
country: Czech Republic
facility: Site CZ42028 Hospital
city: Vysoké Mýto
country: Czech Republic
facility: Site CZ42014 Private Practice
city: Zlin
country: Czech Republic
facility: Site CZ42003 Bata Hospital
city: České Budějovice
country: Czech Republic
facility: Site CZ42007 Private Practice
Study officials:
affiliation: Astellas Pharma s.r.o.
name: Medical and Scientific Affairs manager
role: STUDY_DIRECTOR
References: