Post-operative Peripheral Neuropathic PainNCT02171182
A Study of Efficacy and Safety of Qutenza in Patients With Post-operative Peripheral Neuropathic Pain
An observational study of Post-operative Peripheral Neuropathic Pain, run by Astellas Pharma s.r.o. at 29 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Peripheral Neuropathic Pain
- What is being tested?
- Qutenza
- How many people
- 319 participants
- Where
- 29 sitesCzechia
- Study dates
- Jan 2014to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with post-operative peripheral neuropathic pain
Who may be able to join
- diagnosed peripheral post-operative neuropathic pain
Who cannot join
- hypersensitivity to capsaicin
- pregnancy
- diabetes mellitus
- treatment of face
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Czechia29 sites
Site CZ42019 Hospital
Benešov, 256 01
Site CZ42026 Hospital
Beroun, 266 01
Site CZ42008 Onco Clinic
Brno, 616 00
Site CZ42001 Sv. Anna Hospital
Brno, 626 00
Site CZ42007 Private Practice
České Budějovice, 370 03
Site CZ42015 Hospital
Havlíčkův Brod, 580 02
Site CZ42029 Hospital
Hořovice, 268 01
Site CZ42009 University Hospital
Hradec Králové, 500 02
Site CZ42004 Hospital
Jihlava, 586 02
Site CZ42022 Hospital
Karlovy Vary, 360 02
Site CZ42017 Hospital
Klatovy, 339 00
Site CZ42025 Private Practice
Krnov, 794 01
Site CZ42016 Hospital
Liberec, 460 01
Site CZ42023 Hospital
Mladá Boleslav, 293 01
Site CZ42020 Hospital
New Town, 549 01
Site CZ42010 University Hospital
Olomouc, 770 00
Site CZ42012 Hospital
Opava, 746 00
Site CZ42002 University Hospital
Ostrava, 701 00
Site CZ42006 University Hospital
Pilsen, 320 00
Site CZ42013 Hospital
Prague, 141 00
Site CZ42018 Rheumatological Institute
Prague, 141 01
Site CZ42005 University Hospital
Prague, 152 00
Site CZ42021 Military Hospital
Prague, 161 00
Site CZ42027 Hospital
Semily, 513 01
Site CZ42011 Hospital
Sokolov, 356 00
Site CZ42024 Hospital
Teplice, 415 00
Site CZ42028 Hospital
Uherské Hradiště, 686 02
Site CZ42014 Private Practice
Vysoké Mýto, 566 01
Site CZ42003 Bata Hospital
Zlín, 760 01
About this study
Official title: 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.
- Being tested
- Qutenza
- Keywords
- Qutenza, 8% capsaicin patch, Non-interventional, Post-operative peripheral neuropathic pain, Observational, Czech Republic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QutenzaDrug
Also called NGX-4010,, A0805,, Capsaicin
capsaicin patch
| Study group | Role | What they receive |
|---|---|---|
| Qutenza patients w/ post-operative peripheral neuropathic pain | Not described Receives: Drug: Qutenza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage rate of responders
at least 30% decrease in pain intensity as compared to the baseline
Measured: Baseline, Week 13
Secondary outcomes (10)
Basic demographic parameters
age, gender, history of the disease, other diagnoses
Measured: Baseline
Previous treatment of neuropathy
type of treatment, dosage, combination, treatment line number
Measured: Baseline
Reason for a change in the therapy
Measured: Baseline
Dose
number of patches, area of application and frequency of treatment with 8% capsaicin
Measured: Baseline, Week 13 and Week 26
Size of the area affected by neuropathic pain
Measured: Baseline, Week 13 and Week 26
Concomitant neuropathic medication
Measured: Baseline, Week 13 and Week 26
Efficacy of treatment
changes in NPRS score between weeks 0 and week 8, week 13 and week 26
Measured: Baseline, Week 8, Week 13 and Week 26
Quality of life questionnaire (EQ-5D)
Measured: Baseline, Week 8, Week 13 and Week 26
Consumption of rescue analgesic medication
Measured: Baseline, Week 8, Week 13 and Week 26
Consumption of additional medical care for neuropathic pain
extra visits, hospitalisation
Measured: Baseline, Week 8, Week 13 and Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative Peripheral Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma s.r.o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical and Scientific Affairs manager, Study director, Astellas Pharma s.r.o.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171182
- Sponsor's protocol ID
- 0805-MA-1001
- Status last verified
- Feb 2016
- First submitted
- 20 Jun 2014
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Post-registration Clinical Study of Efficacy and Safety of Qutenza in Patients With Post-operative Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT02171182
- Acronym / sponsor ID
- 0805-MA-1001
- Keywords
- Qutenza, 8% capsaicin patch, Non-interventional, Post-operative peripheral neuropathic pain, Observational, Czech Republic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Astellas Pharma s.r.o.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qutenza patients w/ post-operative peripheral neuropathic pain | – | Drug: Qutenza |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with post-operative peripheral neuropathic pain
Key inclusion criteria (1 listed)
- diagnosed peripheral post-operative neuropathic pain
Key exclusion criteria (4 listed)
- hypersensitivity to capsaicin
- pregnancy
- diabetes mellitus
- treatment of face
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QutenzaAlso: NGX-4010,, A0805,, Capsaicincapsaicin patch | Drug | Qutenza patients w/ post-operative peripheral neuropathic pain |
Primary outcome
Percentage rate of responders
Time frame: Baseline, Week 13
at least 30% decrease in pain intensity as compared to the baseline
10 secondary outcomes
Basic demographic parameters
Time frame: Baseline
Previous treatment of neuropathy
Time frame: Baseline
Reason for a change in the therapy
Time frame: Baseline
Dose
Time frame: Baseline, Week 13 and Week 26
Size of the area affected by neuropathic pain
Time frame: Baseline, Week 13 and Week 26
Concomitant neuropathic medication
Time frame: Baseline, Week 13 and Week 26
Efficacy of treatment
Time frame: Baseline, Week 8, Week 13 and Week 26
Quality of life questionnaire (EQ-5D)
Time frame: Baseline, Week 8, Week 13 and Week 26
Consumption of rescue analgesic medication
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical and Scientific Affairs manager study director
Astellas Pharma s.r.o.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Peripheral Neuropathic Pain, run by Astellas Pharma s.r.o. at 29 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage rate of responders (time frame: Baseline, Week 13). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.