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

February 5, 2016 updated by: Astellas Pharma s.r.o.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

319

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Benešov, Czech Republic, 256 01
        • Site CZ42019 Hospital
      • Beroun, Czech Republic, 266 01
        • Site CZ42026 Hospital
      • Brno, Czech Republic, 616 00
        • Site CZ42008 Onco Clinic
      • Brno, Czech Republic, 626 00
        • Site CZ42001 Sv. Anna Hospital
      • Havlíčkův Brod, Czech Republic, 580 02
        • Site CZ42015 Hospital
      • Hořovice, Czech Republic, 268 01
        • Site CZ42029 Hospital
      • Hradec Králové, Czech Republic, 500 02
        • Site CZ42009 University Hospital
      • Jihlava, Czech Republic, 586 02
        • Site CZ42004 Hospital
      • Karlovy Vary, Czech Republic, 360 02
        • Site CZ42022 Hospital
      • Klatovy, Czech Republic, 339 00
        • Site CZ42017 Hospital
      • Krnov, Czech Republic, 794 01
        • Site CZ42025 Private Practice
      • Liberec, Czech Republic, 460 01
        • Site CZ42016 Hospital
      • Mladá Boleslav, Czech Republic, 293 01
        • Site CZ42023 Hospital
      • Nové Město, Czech Republic, 549 01
        • Site CZ42020 Hospital
      • Olomouc, Czech Republic, 770 00
        • Site CZ42010 University Hospital
      • Opava, Czech Republic, 746 00
        • Site CZ42012 Hospital
      • Ostrava, Czech Republic, 701 00
        • Site CZ42002 University Hospital
      • Plzeň, Czech Republic, 320 00
        • Site CZ42006 University Hospital
      • Prague 4, Czech Republic, 141 00
        • Site CZ42013 Hospital
      • Prague 4, Czech Republic, 141 01
        • Site CZ42018 Rheumatological Institute
      • Prague 5, Czech Republic, 152 00
        • Site CZ42005 University Hospital
      • Prague 6, Czech Republic, 161 00
        • Site CZ42021 Military Hospital
      • Semily, Czech Republic, 513 01
        • Site CZ42027 Hospital
      • Sokolov, Czech Republic, 356 00
        • Site CZ42011 Hospital
      • Teplice, Czech Republic, 415 00
        • Site CZ42024 Hospital
      • Uherské Hradiště, Czech Republic, 686 02
        • Site CZ42028 Hospital
      • Vysoké Mýto, Czech Republic, 566 01
        • Site CZ42014 Private Practice
      • Zlin, Czech Republic, 760 01
        • Site CZ42003 Bata Hospital
      • České Budějovice, Czech Republic, 370 03
        • Site CZ42007 Private Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with post-operative peripheral neuropathic pain

Description

Inclusion Criteria:

  • diagnosed peripheral post-operative neuropathic pain

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Qutenza patients w/ post-operative peripheral neuropathic pain
Drug: Qutenza
capsaicin patch
Other Names:
  • Capsaicin
  • NGX-4010,
  • A0805,

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma s.r.o.

Investigators

  • Study Director: Medical and Scientific Affairs manager, Astellas Pharma s.r.o.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

June 20, 2014

First Submitted That Met QC Criteria

June 20, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

February 5, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0805-MA-1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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