A Study of Efficacy and Safety of Qutenza in Patients With Post-operative Peripheral Neuropathic Pain

Completed

• Conditions: Post-operative Peripheral Neuropathic Pain
• Interventions: Drug: Qutenza

• Registration Number: NCT02171182
• Lead Sponsor: Astellas Pharma s.r.o.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-06-20
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-24
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-05
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 319

Inclusion Criteria

• diagnosed peripheral post-operative neuropathic pain

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Qutenza patients w/ post-operative peripheral neuropathic pain	Qutenza	-

Primary Outcome Measures

Name	Time	Method
Percentage rate of responders	Baseline, Week 13	at least 30% decrease in pain intensity as compared to the baseline

Secondary Outcome Measures

Name	Time	Method
Basic demographic parameters	Baseline	age, gender, history of the disease, other diagnoses
Previous treatment of neuropathy	Baseline	type of treatment, dosage, combination, treatment line number
Reason for a change in the therapy	Baseline
Dose	Baseline, Week 13 and Week 26	number of patches, area of application and frequency of treatment with 8% capsaicin
Size of the area affected by neuropathic pain	Baseline, Week 13 and Week 26
Concomitant neuropathic medication	Baseline, Week 13 and Week 26
Efficacy of treatment	Baseline, Week 8, Week 13 and Week 26	changes in NPRS score between weeks 0 and week 8, week 13 and week 26
Quality of life questionnaire (EQ-5D)	Baseline, Week 8, Week 13 and Week 26
Consumption of rescue analgesic medication	Baseline, Week 8, Week 13 and Week 26
Consumption of additional medical care for neuropathic pain	Baseline, Week 8, Week 13 and Week 26	extra visits, hospitalisation

Trial Locations

Locations (29)

Site CZ42019 Hospital; 🇨🇿 Benešov, Czech Republic

Site CZ42008 Onco Clinic; 🇨🇿 Brno, Czech Republic

Site CZ42001 Sv. Anna Hospital; 🇨🇿 Brno, Czech Republic

Site CZ42015 Hospital; 🇨🇿 Havlíčkův Brod, Czech Republic

Site CZ42017 Hospital; 🇨🇿 Klatovy, Czech Republic

Site CZ42029 Hospital; 🇨🇿 Hořovice, Czech Republic

Site CZ42018 Rheumatological Institute; 🇨🇿 Prague 4, Czech Republic

Site CZ42005 University Hospital; 🇨🇿 Prague 5, Czech Republic

Site CZ42025 Private Practice; 🇨🇿 Krnov, Czech Republic

Site CZ42016 Hospital; 🇨🇿 Liberec, Czech Republic

Site CZ42026 Hospital; 🇨🇿 Beroun, Czech Republic

Site CZ42004 Hospital; 🇨🇿 Jihlava, Czech Republic

Site CZ42009 University Hospital; 🇨🇿 Hradec Králové, Czech Republic

Site CZ42022 Hospital; 🇨🇿 Karlovy Vary, Czech Republic

Site CZ42023 Hospital; 🇨🇿 Mladá Boleslav, Czech Republic

Site CZ42011 Hospital; 🇨🇿 Sokolov, Czech Republic

Site CZ42020 Hospital; 🇨🇿 Nové Město, Czech Republic

Site CZ42012 Hospital; 🇨🇿 Opava, Czech Republic

Site CZ42010 University Hospital; 🇨🇿 Olomouc, Czech Republic

Site CZ42002 University Hospital; 🇨🇿 Ostrava, Czech Republic

Site CZ42013 Hospital; 🇨🇿 Prague 4, Czech Republic

Site CZ42006 University Hospital; 🇨🇿 Plzeň, Czech Republic

Site CZ42021 Military Hospital; 🇨🇿 Prague 6, Czech Republic

Site CZ42027 Hospital; 🇨🇿 Semily, Czech Republic

Site CZ42024 Hospital; 🇨🇿 Teplice, Czech Republic

Site CZ42028 Hospital; 🇨🇿 Uherské Hradiště, Czech Republic

Site CZ42003 Bata Hospital; 🇨🇿 Zlin, Czech Republic

Site CZ42014 Private Practice; 🇨🇿 Vysoké Mýto, Czech Republic

Site CZ42007 Private Practice; 🇨🇿 České Budějovice, Czech Republic