Observation of the Use of QUTENZA™ in Standard Clinical Practice
- Registration Number
- NCT01737294
- Lead Sponsor
- Astellas Pharma Europe Ltd.
- Brief Summary
This non-interventional study will evaluate the efficacy, tolerability, health related quality of life and use of health resources associated with QUTENZA treatment when QUTENZA is used in standard clinical practice.
The patient's primary diagnosis of peripheral neuropathic pain (PNP) will be classified into subtypes: post-herpetic neuralgia (PHN); HIV-associated neuropathy (HIV-AN); neuropathic back pain; cancer-related neuropathic pain; post-operative \& post-traumatic neuropathic pain; and 'other' neuropathies.
- Detailed Description
A detailed medical history will be taken, with particular emphasis on the primary PNP diagnosis. In addition to all current neuropathic pain medications, all previous therapies (pharmacological and surgical) for PNP from the point of primary diagnosis will be documented.
QUTENZA treatments may be repeated up to every 90 days, in line with the Summary of Product Characteristics document (SPC) as determined by the persistence or return of pain.
Patients who have not required treatment for 365 days or longer may re-enter a treatment cycle if their treating physician decides to retreat them with QUTENZA in the course of standard clinical management.
The duration of participation for each patient will be at least 12 months following first QUTENZA treatment.
Short questionnaires will be completed by the investigator whilst in contact with the patient (either in person or by telephone) at the following time points: 1) Screening prior to the first QUTENZA treatment; 2) at each QUTENZA treatment visit; 3) 2 weeks, 8 weeks following the first QUTENZA treatment 4) 12 weeks following each QUTENZA treatment; 5) any additional contact with the patient outside the protocol schedule.
For patients not returning for retreatment with QUTENZA within any of 6 months, 9 months, and 1 year of their previous QUTENZA treatment further follow-up questionnaires will be completed.
End of study (EoS) is defined as one year after the last patient enrolled receives their first QUTENZA treatment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 429
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- The investigator has decided to treat the patient with QUTENZA as part of provision of standard care for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain
-
- The patient is willing and able to comply with protocol requirements for the duration of study participation
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- The neuropathic painful areas are located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes
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- The patient has a history of Type I or Type II diabetes mellitus
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- The patient has a diagnosis of any major psychiatric disorder or evidence of cognitive impairment including dementia that, in the opinion of the investigator, may interfere with patient's ability to complete study evaluations
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- The patient has received any prior treatment with QUTENZA patches, including blinded patches administered as part of a clinical trial
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- The patient has hypersensitivity to capsaicin (i.e. chilli peppers or over-the-counter [OTC] capsaicin products), any QUTENZA excipients or adhesives, or local anesthetics
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- The patient has participated in any other clinical study or received an investigational drug within 30 days prior to Screening Visit
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- The patient currently engages in any active substance abuse or has a history of chronic substance abuse within 1 year prior to the Screening Visit; or any prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator
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- The patient, in the opinion of the investigator, is not suitable to participate in this NIS for any reason
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Treatment with QUTENZA Qutenza exposure Patients with Peripheral Neuropathic Pain
- Primary Outcome Measures
Name Time Method Percent change in average pain NPRS (Numeric Pain Rating Scale) scores From Baseline to mean of all scores recorded between week 2 and week 8 following first treatment Time to retreatment Between 1st & 2nd treatments (up to a maximum of 24 months) From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
- Secondary Outcome Measures
Name Time Method Proportion of patients achieving 50% decrease in average pain NPRS score From Baseline to mean of all scores recorded between weeks 2 & 8 following 1st treatment Absolute change in "average pain" NPRS score From baseline to the average of pain scores assessed between Weeks 2 & 12 following 1st and subsequent treatment(s) From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
Proportion of patients achieving 30% decrease in average pain NPRS score From Baseline to mean of all scores recorded between weeks 2 & 8 following 1st treatment Proportion of patients achieving a 30% decrease in their "average pain" NPRS score (maintenance response) From Baseline to the mean of all scores between week 2 and week 8 and between week 2 and week 12 following retreatment(s) From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
Percent change in "average pain" NPRS score From baseline to mean of all scores between Week 2 and Week 8 and Weeks 2 and Week 12 following retreatment(s) From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
Change in health-related quality of life From baseline to End of Study (up to 24 months) Measured by the EQ-5D (Euroqol-5 dimensions) index
Patient Global Impression of Change At each follow-up after 1st and subsequent treatment(s) (up to a maximum of 24 months) Percentage reporting any degree of improvement. Week 2 after 1st Treatment to End of Study
Change in Work Productivity and Activity Impairment scores Baseline, week 12, 6 months, 9 months, and 12 months after 1st and subsequent treatment(s) Week 2 after 1st Treatment to End of Study
Proportion of patients achieving a 50% decrease in their "average pain" NPRS score (maintenance response) From Baseline to the mean of all scores between week 2 and week 8 and between week 2 and week 12 following retreatment(s) From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
Mean "Average pain" NPRS score At each time point following 1st and subsequent treatment(s) (up to a maximum of 24 months) From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
Patient Self Assessment of Treatment At 12 weeks, 6 months, 9 months, and 12 months after 1st and subsequent retreatment(s) Week 2 after 1st Treatment to End of Study
Number of QUTENZA patches used with each treatment Day 1 of each treatment Change in health resource use From baseline to End of Study (up to 24 months) Number of contacts with health professionals in prior 4 weeks
Percentage of patients requiring rescue measures during and after treatment with QUTENZA From Baseline to End of Study (up to 24 months) Proportion of patients achieving a 2-point absolute decrease in their "average pain" NPRS score From baseline to the average of pain scores assessed between Weeks 2 & 12 following 1st and subsequent treatment(s) From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
Relative change in treatment area size At first treatment and each retreatment (up to a maximum of 24 months) From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
Change in concomitant pain medications From baseline to End of Study (up to 24 months) Percentage remaining on opioids, anticonvulsants, antidepressants
Time (in days) between successive retreatments Between successive retreatments (up to a maximum of 24 months) From the 1st treatment to the End of Study (The End of Study is defined as the completion of one year of follow-up from the first Qutenza treatment of the last patient enrolled)
Trial Locations
- Locations (50)
Site 101 Krankenhaus der Barmherzigen Brüder Abteilung für Anästhesiologie, Intensivmedizin und Schmerztherapie Johannes von Gott Platz 1
🇦🇹Vienna, Austria
Site 206 Dimosthenis Mitsikostas Hellenic Navy Hospital of Athens - Neurology Clinic
🇬🇷Athens, Attica, Greece
Site 106 Interdisziplinäre Schmerzambulanz Univ. Klinik f. Anästhesiologie und Intensivmedizin Graz Auenbruggerplatz 29
🇦🇹Linz, Austria
Site 204 Nikolaos Vlaikidis General Hospital of Thessaloniki ''G.Papanikolaou'' - 3rd Neurology Clinic
🇬🇷Thessaloniki, Greece
Site 205 Antonios Kodounis 251 General Airforce Hospital of Athens - Neurology Clinic
🇬🇷Athens, Attica, Greece
Site 609 Hospital de Faro
🇵🇹Faro, Portugal
Site 107 Interdisziplinäre Schmerzambulanz Univ. Klinik f. Anästhesiologie und Intensivmedizin Graz, Auenbruggerplatz 29
🇦🇹Graz, Austria
Site 202 Antonios Tavernarakis General Hospital of Athens ''Evangelismos'' - Neurology Clinic
🇬🇷Athens, Attica, Greece
Site 611 Centro Hospitalar Cova da Beira - Hospital Universitário Quinta do Alvito
🇵🇹Covilhã, Portugal
Site 203 Georgios Georgiadis General Hospital of Thessaloniki ''Ippokratio'' - Neurology Clinic
🇬🇷Thessaloniki, Greece
Site 702 Hospital Municipal de Badalona
🇪🇸Badalona, Barcelona, Spain
Site 306 Ospedale regionale "Umberto Parini"
🇮🇹Aosta, AO, Italy
Site 302 Ospedale di Stato della Repubblica di San Marino
🇮🇹Borgo Maggiore, RSM, Italy
Site 304 Ospedale SS. Annunziata
🇮🇹Taranto, TA, Italy
Site 601 Centro Hospitalar Lisboa Norte- Hospital Santa Maria
🇵🇹Lisbon, Portugal
Site 212 2 Pindarou and Tseva Str, Koumerki
🇬🇷Thiva, Greece
Site 103 Abteilung für Anästhesiologie und Intensivmedizin LKH Hartberg
🇦🇹Graz, Austria
Site 104 Abteilung für Anästhesie und allgemeine Intensivmedizin Allgemein öffentliches Klinikum-Klagenfurt am Wörthersee St. Veiter Strasse 47
🇦🇹Hartberg, Austria
Site 105 Abteilung für Anästhesiologie und operative Intensivmedizin Allgemeines Krankenhaus Linz Krankenhausstraße 9
🇦🇹Klagenfurt am Wörthersee, Austria
Site 102 Krankenhaus der Elisabethinen GmbH Abteilung für Anästhesie und Intensivmedizin Elisabethinergasse 14
🇦🇹Vienna, Austria
Site 209 Grigorios Panagopoulos- General Hospital of Athens ''G.Gennimatas'' - Neurology Clinic
🇬🇷Athens, Attica, Greece
Site 211 Panagiotis Kokotis Aeginitio University Hospital of Athens - A' Neurology Clinic
🇬🇷Athens, Attica, Greece
Site 213 Mediterraneo Hospital
🇬🇷Athens, Greece
Site 210 General Hospital of Athens ''G.Gennimatas'' - Neurology Clinic, Athens
🇬🇷Attica, Greece
Site 208 Alexandros Papadimitriou University General Hospital of Larisa - Neurology Clinic
🇬🇷Larisa, Greece
Site 305 Azienda Ospedaliero-Universitaria Consorziale Policlinico
🇮🇹Bari, BA, Italy
Site 308 Spedali Riuniti di Bergamo
🇮🇹Bergamo, BG, Italy
Site 301 A.O. Spedali Civili di Brescia
🇮🇹Brescia, BS, Italy
Site 303 L'INM Neuromed, Istituto Neurologico Mediterraneo
🇮🇹Pozzilli, IS, Italy
Site 608 Hospital Divino Espirito Santo, E.P.E.
🇵🇹Acores, Portugal
Site 607 Hospital Garcia da Orta
🇵🇹Almada, Portugal
Site 602 Hospital Professor Dr. Fernando da Fonseca
🇵🇹Amadora, Portugal
Site 603 Hospital Infante D. Pedro EPE
🇵🇹Aveiro, Portugal
Site 605 Hospital S. João da Madeira
🇵🇹Madeira, Portugal
Site 606 Centro Hospitalar do Porto-Hospital Santo António
🇵🇹Porto, Portugal
Site 604 Hospital São João
🇵🇹Porto, Portugal
Site 610 Hospital S. Teotónio
🇵🇹Viseu, Portugal
Site 704 Hospital de Basurto
🇪🇸Bilbao, Vizcaya, Spain
Site 707 Hospital de Galdakano
🇪🇸Galdakano, Vizcaya, Spain
Site 703 Fundació Puigvert
🇪🇸Barcelona, Spain
Site 705 Hospital Clinic
🇪🇸Barcelona, Spain
Site 706 Complejo Hospitalario de Navarra
🇪🇸Pamplona, Spain
Site 708 Clínica Universitaria de Navarra
🇪🇸Pamplona, Spain
Site 902 Leiter der Schmerzklinik Bethesda-Spital Gellertstrasse 144
🇨🇭Basel, Switzerland
Site 901 Schmerzzentrum St. Gallen Kantonspital St.Gallen
🇨🇭Saint Gallen, Switzerland
Site 804 Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Site 802 West Cumberland General Hospital
🇬🇧Whitehaven, Cumbria, United Kingdom
Site 801 Chelsea and Westminster Hospital
🇬🇧London, United Kingdom
Site 803 Western General Hospital
🇬🇧Edinburgh, United Kingdom
Site 805 Princess Elizabeth Hospital
🇬🇧St Martins, United Kingdom