NCT02171182

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
319

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

February 8, 2016

Status Verified

February 1, 2016

Enrollment Period

1.6 years

First QC Date

June 20, 2014

Last Update Submit

February 5, 2016

Conditions

Post-operative Peripheral Neuropathic Pain

Keywords

Qutenza8% capsaicin patchNon-interventionalPost-operative peripheral neuropathic painObservationalCzech Republic

Outcome Measures

Primary Outcomes (1)

  • Percentage rate of responders

    at least 30% decrease in pain intensity as compared to the baseline

    Baseline, Week 13

Secondary Outcomes (10)

  • Basic demographic parameters

    Baseline

  • Previous treatment of neuropathy

    Baseline

  • Reason for a change in the therapy

    Baseline

  • Dose

    Baseline, Week 13 and Week 26

  • Size of the area affected by neuropathic pain

    Baseline, Week 13 and Week 26

  • +5 more secondary outcomes

Study Arms (1)

Qutenza patients w/ post-operative peripheral neuropathic pain

Drug: Qutenza

Interventions

QutenzaDRUG

capsaicin patch

Also known as: NGX-4010,, A0805,, Capsaicin
Qutenza patients w/ post-operative peripheral neuropathic pain

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with post-operative peripheral neuropathic pain

You may qualify if:

  • diagnosed peripheral post-operative neuropathic pain

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Site CZ42019 Hospital

Benešov, 256 01, Czechia

Location

Site CZ42026 Hospital

Beroun, 266 01, Czechia

Location

Site CZ42008 Onco Clinic

Brno, 616 00, Czechia

Location

Site CZ42001 Sv. Anna Hospital

Brno, 626 00, Czechia

Location

Site CZ42007 Private Practice

České Budějovice, 370 03, Czechia

Location

Site CZ42015 Hospital

Havlíčkův Brod, 580 02, Czechia

Location

Site CZ42029 Hospital

Hořovice, 268 01, Czechia

Location

Site CZ42009 University Hospital

Hradec Králové, 500 02, Czechia

Location

Site CZ42004 Hospital

Jihlava, 586 02, Czechia

Location

Site CZ42022 Hospital

Karlovy Vary, 360 02, Czechia

Location

Site CZ42017 Hospital

Klatovy, 339 00, Czechia

Location

Site CZ42025 Private Practice

Krnov, 794 01, Czechia

Location

Site CZ42016 Hospital

Liberec, 460 01, Czechia

Location

Site CZ42023 Hospital

Mladá Boleslav, 293 01, Czechia

Location

Site CZ42020 Hospital

New Town, 549 01, Czechia

Location

Site CZ42010 University Hospital

Olomouc, 770 00, Czechia

Location

Site CZ42012 Hospital

Opava, 746 00, Czechia

Location

Site CZ42002 University Hospital

Ostrava, 701 00, Czechia

Location

Site CZ42006 University Hospital

Pilsen, 320 00, Czechia

Location

Site CZ42013 Hospital

Prague, 141 00, Czechia

Location

Site CZ42018 Rheumatological Institute

Prague, 141 01, Czechia

Location

Site CZ42005 University Hospital

Prague, 152 00, Czechia

Location

Site CZ42021 Military Hospital

Prague, 161 00, Czechia

Location

Site CZ42027 Hospital

Semily, 513 01, Czechia

Location

Site CZ42011 Hospital

Sokolov, 356 00, Czechia

Location

Site CZ42024 Hospital

Teplice, 415 00, Czechia

Location

Site CZ42028 Hospital

Uherské Hradiště, 686 02, Czechia

Location

Site CZ42014 Private Practice

Vysoké Mýto, 566 01, Czechia

Location

Site CZ42003 Bata Hospital

Zlín, 760 01, Czechia

Location

MeSH Terms

Interventions

Capsaicin

Intervention Hierarchy (Ancestors)

Polyunsaturated AlkamidesAmidesOrganic ChemicalsAlkenesHydrocarbons, AcyclicHydrocarbonsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicSolanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsFatty Acids, MonounsaturatedFatty Acids, UnsaturatedFatty AcidsLipids

Study Officials

  • Medical and Scientific Affairs manager

    Astellas Pharma s.r.o.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2014

First Posted

June 24, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

February 8, 2016

Record last verified: 2016-02

Locations

CZ(29)