Observation of the Use of QUTENZA™ in Standard Clinical Practice

NCT01737294 | Completed

• 1 other identifier: QTZ-EC-0003
• Study Type: observational
• Target: 429
• Locations: 7 countries
• Sites: 50

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.

Conditions

Peripheral Neuropathic Pain

Keywords

Phase IV; Peripheral Neuropathic Pain; QUTENZA

Outcome Measures

Primary Outcomes (2)

• 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

  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)

  Between 1st & 2nd treatments (up to a maximum of 24 months)

Secondary Outcomes (18)

• 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 50% decrease in average pain NPRS score

  From Baseline to mean of all scores recorded between weeks 2 & 8 following 1st treatment

• 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)

• 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)

• 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)

Study Arms (1)

Treatment with QUTENZA

Patients with Peripheral Neuropathic Pain

Drug: Qutenza exposure

Interventions

Qutenza exposure DRUG

Cutaneous patch

Also known as: Capsaicin

Treatment with QUTENZA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving QUTENZA for PNP in routine clinical practice

You may qualify if:

• \. 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

You may not qualify if:

• \. The neuropathic painful areas are located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes
• \. The patient has a history of Type I or Type II diabetes mellitus
• \. 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
• \. The patient has received any prior treatment with QUTENZA patches, including blinded patches administered as part of a clinical trial
• \. 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
• \. The patient has participated in any other clinical study or received an investigational drug within 30 days prior to Screening Visit
• \. 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
• \. The patient, in the opinion of the investigator, is not suitable to participate in this NIS for any reason

Sponsors & Collaborators

• Astellas Pharma Europe Ltd.: lead

Study Sites (50)

Site 103 Abteilung für Anästhesiologie und Intensivmedizin LKH Hartberg

Graz, 8020, Austria

Location

Site 107 Interdisziplinäre Schmerzambulanz Univ. Klinik f. Anästhesiologie und Intensivmedizin Graz, Auenbruggerplatz 29

Graz, 8036, Austria

Location

Site 104 Abteilung für Anästhesie und allgemeine Intensivmedizin Allgemein öffentliches Klinikum-Klagenfurt am Wörthersee St. Veiter Strasse 47

Hartberg, 8230, Austria

Location

Site 105 Abteilung für Anästhesiologie und operative Intensivmedizin Allgemeines Krankenhaus Linz Krankenhausstraße 9

Klagenfurt, 9020, Austria

Location

Site 106 Interdisziplinäre Schmerzambulanz Univ. Klinik f. Anästhesiologie und Intensivmedizin Graz Auenbruggerplatz 29

Linz, 4021, Austria

Location

Site 102 Krankenhaus der Elisabethinen GmbH Abteilung für Anästhesie und Intensivmedizin Elisabethinergasse 14

Vienna, 1020, Austria

Location

Site 101 Krankenhaus der Barmherzigen Brüder Abteilung für Anästhesiologie, Intensivmedizin und Schmerztherapie Johannes von Gott Platz 1

Vienna, 1090, Austria

Location

Site 202 Antonios Tavernarakis General Hospital of Athens ''Evangelismos'' - Neurology Clinic

Athens, Attica, 10676, Greece

Location

Site 206 Dimosthenis Mitsikostas Hellenic Navy Hospital of Athens - Neurology Clinic

Athens, Attica, 11521, Greece

Location

Site 205 Antonios Kodounis 251 General Airforce Hospital of Athens - Neurology Clinic

Athens, Attica, 11525, Greece

Location

Site 209 Grigorios Panagopoulos- General Hospital of Athens ''G.Gennimatas'' - Neurology Clinic

Athens, Attica, 11527, Greece

Location

Site 211 Panagiotis Kokotis Aeginitio University Hospital of Athens - A' Neurology Clinic

Athens, Attica, 11528, Greece

Location

Site 208 Alexandros Papadimitriou University General Hospital of Larisa - Neurology Clinic

Larissa, Larisa, 41110, Greece

Location

Site 203 Georgios Georgiadis General Hospital of Thessaloniki ''Ippokratio'' - Neurology Clinic

Thessaloniki, Thessaloniki, 54642, Greece

Location

Site 204 Nikolaos Vlaikidis General Hospital of Thessaloniki ''G.Papanikolaou'' - 3rd Neurology Clinic

Thessaloniki, Thessaloniki, 57010, Greece

Location

Site 213 Mediterraneo Hospital

Athens, Greece

Location

Site 210 General Hospital of Athens ''G.Gennimatas'' - Neurology Clinic, Athens

Attica, 11528, Greece

Location

Site 212 2 Pindarou and Tseva Str, Koumerki

Thebes, 32200, Greece

Location

Site 306 Ospedale regionale "Umberto Parini"

Aosta, AO, 11100, Italy

Location

Site 305 Azienda Ospedaliero-Universitaria Consorziale Policlinico

Bari, BA, 70100, Italy

Location

Site 308 Spedali Riuniti di Bergamo

Bergamo, BG, 24100, Italy

Location

Site 301 A.O. Spedali Civili di Brescia

Brescia, BS, 25100, Italy

Location

Site 303 L'INM Neuromed, Istituto Neurologico Mediterraneo

Pozzilli, IS, 86077, Italy

Location

Site 302 Ospedale di Stato della Repubblica di San Marino

Borgo Maggiore, RSM, 47893, Italy

Location

Site 304 Ospedale SS. Annunziata

Taranto, TA, 74100, Italy

Location

Site 608 Hospital Divino Espirito Santo, E.P.E.

Açores, 9500-370, Portugal

Location

Site 607 Hospital Garcia da Orta

Almada, 2801-951, Portugal

Location

Site 602 Hospital Professor Dr. Fernando da Fonseca

Amadora, 2720-276, Portugal

Location

Site 603 Hospital Infante D. Pedro EPE

Aveiro, 3814-501, Portugal

Location

Site 611 Centro Hospitalar Cova da Beira - Hospital Universitário Quinta do Alvito

Covilha, 6200-251, Portugal

Location

Site 609 Hospital de Faro

Faro, 8000-386, Portugal

Location

Site 601 Centro Hospitalar Lisboa Norte- Hospital Santa Maria

Lisbon, 1649-035, Portugal

Location

Site 605 Hospital S. João da Madeira

Madeirã, 3700-190, Portugal

Location

Site 606 Centro Hospitalar do Porto-Hospital Santo António

Porto, 4099-001, Portugal

Location

Site 604 Hospital São João

Porto, 4200 - 319, Portugal

Location

Site 610 Hospital S. Teotónio

Viseu, 3504-509, Portugal

Location

Site 702 Hospital Municipal de Badalona

Badalona, Barcelona, 8911, Spain

Location

Site 703 Fundació Puigvert

Barcelona, Barcelona, 8025, Spain

Location

Site 705 Hospital Clinic

Barcelona, Barcelona, 8036, Spain

Location

Site 706 Complejo Hospitalario de Navarra

Pamplona, Pamplona, 31008, Spain

Location

Site 708 Clínica Universitaria de Navarra

Pamplona, Pamplona, 31008, Spain

Location

Site 704 Hospital de Basurto

Bilbao, Vizcaya, 48013, Spain

Location

Site 707 Hospital de Galdakano

Galdakano, Vizcaya, 48960, Spain

Location

Site 902 Leiter der Schmerzklinik Bethesda-Spital Gellertstrasse 144

Basel, 4052, Switzerland

Location

Site 901 Schmerzzentrum St. Gallen Kantonspital St.Gallen

Sankt Gallen, 9007, Switzerland

Location

Site 802 West Cumberland General Hospital

Whitehaven, Cumbria, CA28 8JG, United Kingdom

Location

Site 804 Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Site 803 Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

Location

Site 801 Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

Location

Site 805 Princess Elizabeth Hospital

St Martins, GY1 3EX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 28431564 DERIVED

MeSH Terms

Interventions

Capsaicin

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Company Medical Expert

  Astellas Pharma Europe Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: November 29, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: October 6, 2014

Record last verified: 2014-10

Locations

ES (7); IT (7); GR (11); AU (7); GB (5); CH (2); PT (11)