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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02171182

Enrollment

319

Registered

2014-06-24

Start date

2014-01-31

Completion date

2015-08-31

Last updated

2016-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-operative Peripheral Neuropathic Pain

Keywords

Qutenza, 8% capsaicin patch, Non-interventional, Post-operative peripheral neuropathic pain, Observational, Czech Republic

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.

Interventions

DRUGQutenza

capsaicin patch

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* diagnosed peripheral post-operative neuropathic pain

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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
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	—
Reason for a change in the therapy	Baseline	—
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
Concomitant neuropathic medication	Baseline, Week 13 and Week 26	—

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026