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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma s.r.o.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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