Post-operative Peripheral Neuropathic Pain Clinical Trial
Official title:
A Non-interventional Post-registration Clinical Study of Efficacy and Safety of Qutenza in Patients With Post-operative Peripheral Neuropathic Pain
| Verified date | February 2016 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Czech Republic: State Institute for Drug Control |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 319 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - diagnosed peripheral post-operative neuropathic pain Exclusion Criteria: - hypersensitivity to capsaicin - pregnancy - diabetes mellitus - treatment of face |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Czech Republic | Site CZ42019 Hospital | Benešov | |
| Czech Republic | Site CZ42026 Hospital | Beroun | |
| Czech Republic | Site CZ42001 Sv. Anna Hospital | Brno | |
| Czech Republic | Site CZ42008 Onco Clinic | Brno | |
| Czech Republic | Site CZ42007 Private Practice | Ceské Budejovice | |
| Czech Republic | Site CZ42015 Hospital | Havlíckuv Brod | |
| Czech Republic | Site CZ42029 Hospital | Horovice | |
| Czech Republic | Site CZ42009 University Hospital | Hradec Králové | |
| Czech Republic | Site CZ42004 Hospital | Jihlava | |
| Czech Republic | Site CZ42022 Hospital | Karlovy Vary | |
| Czech Republic | Site CZ42017 Hospital | Klatovy | |
| Czech Republic | Site CZ42025 Private Practice | Krnov | |
| Czech Republic | Site CZ42016 Hospital | Liberec | |
| Czech Republic | Site CZ42023 Hospital | Mladá Boleslav | |
| Czech Republic | Site CZ42020 Hospital | Nové Mesto | |
| Czech Republic | Site CZ42010 University Hospital | Olomouc | |
| Czech Republic | Site CZ42012 Hospital | Opava | |
| Czech Republic | Site CZ42002 University Hospital | Ostrava | |
| Czech Republic | Site CZ42006 University Hospital | Plzen | |
| Czech Republic | Site CZ42013 Hospital | Prague 4 | |
| Czech Republic | Site CZ42018 Rheumatological Institute | Prague 4 | |
| Czech Republic | Site CZ42005 University Hospital | Prague 5 | |
| Czech Republic | Site CZ42021 Military Hospital | Prague 6 | |
| Czech Republic | Site CZ42027 Hospital | Semily | |
| Czech Republic | Site CZ42011 Hospital | Sokolov | |
| Czech Republic | Site CZ42024 Hospital | Teplice | |
| Czech Republic | Site CZ42028 Hospital | Uherské Hradište | |
| Czech Republic | Site CZ42014 Private Practice | Vysoké Mýto | |
| Czech Republic | Site CZ42003 Bata Hospital | Zlin |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma s.r.o. |
Czech Republic,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage rate of responders | at least 30% decrease in pain intensity as compared to the baseline | Baseline, Week 13 | No |
| Secondary | Basic demographic parameters | age, gender, history of the disease, other diagnoses | Baseline | No |
| Secondary | Previous treatment of neuropathy | type of treatment, dosage, combination, treatment line number | Baseline | No |
| Secondary | Reason for a change in the therapy | Baseline | No | |
| Secondary | Dose | number of patches, area of application and frequency of treatment with 8% capsaicin | Baseline, Week 13 and Week 26 | No |
| Secondary | Size of the area affected by neuropathic pain | Baseline, Week 13 and Week 26 | No | |
| Secondary | Concomitant neuropathic medication | Baseline, Week 13 and Week 26 | No | |
| Secondary | Efficacy of treatment | changes in NPRS score between weeks 0 and week 8, week 13 and week 26 | Baseline, Week 8, Week 13 and Week 26 | No |
| Secondary | Quality of life questionnaire (EQ-5D) | Baseline, Week 8, Week 13 and Week 26 | No | |
| Secondary | Consumption of rescue analgesic medication | Baseline, Week 8, Week 13 and Week 26 | No | |
| Secondary | Consumption of additional medical care for neuropathic pain | extra visits, hospitalisation | Baseline, Week 8, Week 13 and Week 26 | No |