Observation of the Use of QUTENZA™ in Standard Clinical Practice
NCT ID: NCT01737294
Last Updated: 2014-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
429 participants
OBSERVATIONAL
2012-02-29
2014-08-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Treatment with QUTENZA
Patients with Peripheral Neuropathic Pain
Qutenza exposure
Cutaneous patch
Interventions
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Qutenza exposure
Cutaneous patch
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 2\. The patient is willing and able to comply with protocol requirements for the duration of study participation
Exclusion Criteria
* 2\. The patient has a history of Type I or Type II diabetes mellitus
* 3\. 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
* 4\. The patient has received any prior treatment with QUTENZA patches, including blinded patches administered as part of a clinical trial
* 5\. 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
* 6\. The patient has participated in any other clinical study or received an investigational drug within 30 days prior to Screening Visit
* 7\. 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
* 8\. The patient, in the opinion of the investigator, is not suitable to participate in this NIS for any reason
18 Years
ALL
No
Sponsors
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Astellas Pharma Europe Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Company Medical Expert
Role: STUDY_DIRECTOR
Astellas Pharma Europe Ltd.
Locations
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Site 103 Abteilung für Anästhesiologie und Intensivmedizin LKH Hartberg
Graz, , Austria
Site 107 Interdisziplinäre Schmerzambulanz Univ. Klinik f. Anästhesiologie und Intensivmedizin Graz, Auenbruggerplatz 29
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, , Austria
Site 106 Interdisziplinäre Schmerzambulanz Univ. Klinik f. Anästhesiologie und Intensivmedizin Graz Auenbruggerplatz 29
Linz, , Austria
Site 102 Krankenhaus der Elisabethinen GmbH Abteilung für Anästhesie und Intensivmedizin Elisabethinergasse 14
Vienna, , Austria
Site 101 Krankenhaus der Barmherzigen Brüder Abteilung für Anästhesiologie, Intensivmedizin und Schmerztherapie Johannes von Gott Platz 1
Vienna, , Austria
Site 202 Antonios Tavernarakis General Hospital of Athens ''Evangelismos'' - Neurology Clinic
Athens, Attica, Greece
Site 206 Dimosthenis Mitsikostas Hellenic Navy Hospital of Athens - Neurology Clinic
Athens, Attica, Greece
Site 205 Antonios Kodounis 251 General Airforce Hospital of Athens - Neurology Clinic
Athens, Attica, Greece
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 208 Alexandros Papadimitriou University General Hospital of Larisa - Neurology Clinic
Larissa, Larisa, Greece
Site 203 Georgios Georgiadis General Hospital of Thessaloniki ''Ippokratio'' - Neurology Clinic
Thessaloniki, Thessaloniki, Greece
Site 204 Nikolaos Vlaikidis General Hospital of Thessaloniki ''G.Papanikolaou'' - 3rd Neurology Clinic
Thessaloniki, Thessaloniki, Greece
Site 213 Mediterraneo Hospital
Athens, , Greece
Site 210 General Hospital of Athens ''G.Gennimatas'' - Neurology Clinic, Athens
Attica, , Greece
Site 212 2 Pindarou and Tseva Str, Koumerki
Thebes, , Greece
Site 306 Ospedale regionale "Umberto Parini"
Aosta, AO, Italy
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 302 Ospedale di Stato della Repubblica di San Marino
Borgo Maggiore, RSM, Italy
Site 304 Ospedale SS. Annunziata
Taranto, TA, Italy
Site 608 Hospital Divino Espirito Santo, E.P.E.
Açores, , 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 611 Centro Hospitalar Cova da Beira - Hospital Universitário Quinta do Alvito
Covilha, , Portugal
Site 609 Hospital de Faro
Faro, , Portugal
Site 601 Centro Hospitalar Lisboa Norte- Hospital Santa Maria
Lisbon, , Portugal
Site 605 Hospital S. João da Madeira
Madeirã, , 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 702 Hospital Municipal de Badalona
Badalona, Barcelona, Spain
Site 703 Fundació Puigvert
Barcelona, Barcelona, Spain
Site 705 Hospital Clinic
Barcelona, Barcelona, Spain
Site 706 Complejo Hospitalario de Navarra
Pamplona, Pamplona, Spain
Site 708 Clínica Universitaria de Navarra
Pamplona, Pamplona, Spain
Site 704 Hospital de Basurto
Bilbao, Vizcaya, Spain
Site 707 Hospital de Galdakano
Galdakano, Vizcaya, Spain
Site 902 Leiter der Schmerzklinik Bethesda-Spital Gellertstrasse 144
Basel, , Switzerland
Site 901 Schmerzzentrum St. Gallen Kantonspital St.Gallen
Sankt Gallen, , Switzerland
Site 802 West Cumberland General Hospital
Whitehaven, Cumbria, United Kingdom
Site 804 Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Site 803 Western General Hospital
Edinburgh, , United Kingdom
Site 801 Chelsea and Westminster Hospital
London, , United Kingdom
Site 805 Princess Elizabeth Hospital
St Martins, , United Kingdom
Countries
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References
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Mankowski C, Poole CD, Ernault E, Thomas R, Berni E, Currie CJ, Treadwell C, Calvo JI, Plastira C, Zafeiropoulou E, Odeyemi I. Effectiveness of the capsaicin 8% patch in the management of peripheral neuropathic pain in European clinical practice: the ASCEND study. BMC Neurol. 2017 Apr 21;17(1):80. doi: 10.1186/s12883-017-0836-z.
Other Identifiers
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QTZ-EC-0003
Identifier Type: -
Identifier Source: org_study_id
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