Painthresholds under high-dose topical Capsaicin

Heat-, Cold-, and Mechanical Painthresholds under exposition of high dose topical Capsaicin

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002546-36-AT

Enrollment

Registered

2013-09-16

Start date

2013-10-01

Completion date

Unknown

Last updated

2022-08-08

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

Conditions

Pain MedDRA version: 16.0 Level: PT Classification code 10003051 Term: Application site pain System Organ Class: 10018065 - General disorders and administration site conditions

Interventions

Trade Name: Qutenza Product Name: Qutenza Pharmaceutical Form: Cutaneous patch INN or Proposed INN: capsaicin CAS Number: 404-86-4 Other descriptive name: CAPSAICIN Concentration unit: % (W/W) percent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: male and female healthy volunteers aged between 18 and 80 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2

Exclusion criteria

Exclusion criteria: injury or surgery of both forearms hypersensitivity towards Cpasaicin or Qutenza Pregnant or breast-feeding female participants Participation in another drug trial prior use of Qutenza

Design outcomes

Primary

Measure	Time frame
Main Objective: Determination of heat-painthreshold under exposition of high-dose Capsaicin for 60 minutes;Secondary Objective: Determination of cold-painthreshold under exposition of high-dose Capsaicin for 60 minutes Determination of mechanical-painthreshold under exposition of high-dose Capsaicin for 60 minutes;Primary end point(s): difference of the heat-painthresholds under Capsaicin treatment vs. placebo treatment ;Timepoint(s) of evaluation of this end point: after 60 minutes of administration	—

Measure

Time frame

Main Objective: Determination of heat-painthreshold under exposition of high-dose Capsaicin for 60 minutes;Secondary Objective: Determination of cold-painthreshold under exposition of high-dose Capsaicin for 60 minutes Determination of mechanical-painthreshold under exposition of high-dose Capsaicin for 60 minutes;Primary end point(s): difference of the heat-painthresholds under Capsaicin treatment vs. placebo treatment ;Timepoint(s) of evaluation of this end point: after 60 minutes of administration

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Secondary

Measure	Time frame
Secondary end point(s): difference of the cold-painthresholds under Capsaicin treatment vs. placebo treatment at 0, 15, 30, 45, 60 minutes of treatment and 2, 4, and 8 weeks after difference of the mechanical-painthresholds under Capsaicin treatment vs. placebo treatment after 60 minutes of treatment and 2, 4, and 8 weeks difference of the heat-painthresholds under Capsaicin treatment vs. placebo treatment at 0, 15, 30, 45 minutes of treatment and 2, 4, and 8 weeks after ;Timepoint(s) of evaluation of this end point: 0, 15, 30, 45, 60 minutes of treatment and 2, 4, and 8 weeks after	—

Measure

Time frame

Secondary end point(s): difference of the cold-painthresholds under Capsaicin treatment vs. placebo treatment at 0, 15, 30, 45, 60 minutes of treatment and 2, 4, and 8 weeks after difference of the mechanical-painthresholds under Capsaicin treatment vs. placebo treatment after 60 minutes of treatment and 2, 4, and 8 weeks difference of the heat-painthresholds under Capsaicin treatment vs. placebo treatment at 0, 15, 30, 45 minutes of treatment and 2, 4, and 8 weeks after ;Timepoint(s) of evaluation of this end point: 0, 15, 30, 45, 60 minutes of treatment and 2, 4, and 8 weeks after

—

Countries

Austria

Contacts

Public ContactInvestigator

Medizinische Universität Wien, Universitätsklinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie

00431404004139

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026