Clinical trial NCT01737294: Observation of the Use of QUTENZA™ in Standard Clinical Practice
Official title: The Use of QUTENZA™ in Standard Clinical Practice: a Phase IV, Multicentre, European Non-interventional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Neuropathic Pain
Keywords: Phase IV
Peripheral Neuropathic Pain
QUTENZA
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 429
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving QUTENZA for PNP in routine clinical practice

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.

Eligibility criteria: Inclusion Criteria:

* 1. 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
* 2. The patient is willing and able to comply with protocol requirements for the duration of study participation

Exclusion Criteria:

* 1. The neuropathic painful areas are located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes
* 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

Primary outcomes:
measure: Percent change in average pain NPRS (Numeric Pain Rating Scale) scores
timeFrame: From Baseline to mean of all scores recorded between week 2 and week 8 following first treatment
measure: Time to retreatment
timeFrame: Between 1st & 2nd treatments (up to a maximum of 24 months)
Secondary outcomes:
measure: Proportion of patients achieving 30% decrease in average pain NPRS score
timeFrame: From Baseline to mean of all scores recorded between weeks 2 & 8 following 1st treatment
measure: Proportion of patients achieving 50% decrease in average pain NPRS score
timeFrame: From Baseline to mean of all scores recorded between weeks 2 & 8 following 1st treatment
measure: Percent change in "average pain" NPRS score
timeFrame: From baseline to mean of all scores between Week 2 and Week 8 and Weeks 2 and Week 12 following retreatment(s)
measure: Proportion of patients achieving a 30% decrease in their "average pain" NPRS score (maintenance response)
timeFrame: From Baseline to the mean of all scores between week 2 and week 8 and between week 2 and week 12 following retreatment(s)
measure: Proportion of patients achieving a 50% decrease in their "average pain" NPRS score (maintenance response)
timeFrame: From Baseline to the mean of all scores between week 2 and week 8 and between week 2 and week 12 following retreatment(s)
measure: Absolute change in "average pain" NPRS score
timeFrame: From baseline to the average of pain scores assessed between Weeks 2 & 12 following 1st and subsequent treatment(s)
measure: Proportion of patients achieving a 2-point absolute decrease in their "average pain" NPRS score
timeFrame: From baseline to the average of pain scores assessed between Weeks 2 & 12 following 1st and subsequent treatment(s)
measure: Mean "Average pain" NPRS score
timeFrame: At each time point following 1st and subsequent treatment(s) (up to a maximum of 24 months)
measure: Time (in days) between successive retreatments
timeFrame: Between successive retreatments (up to a maximum of 24 months)
measure: Number of QUTENZA patches used with each treatment
timeFrame: Day 1 of each treatment
measure: Relative change in treatment area size
timeFrame: At first treatment and each retreatment (up to a maximum of 24 months)
measure: Change in concomitant pain medications
timeFrame: From baseline to End of Study (up to 24 months)
measure: Change in health-related quality of life
timeFrame: From baseline to End of Study (up to 24 months)
measure: Change in health resource use
timeFrame: From baseline to End of Study (up to 24 months)
measure: Patient Global Impression of Change
timeFrame: At each follow-up after 1st and subsequent treatment(s) (up to a maximum of 24 months)
measure: Patient Self Assessment of Treatment
timeFrame: At 12 weeks, 6 months, 9 months, and 12 months after 1st and subsequent retreatment(s)
measure: Change in Work Productivity and Activity Impairment scores
timeFrame: Baseline, week 12, 6 months, 9 months, and 12 months after 1st and subsequent treatment(s)
measure: Percentage of patients requiring rescue measures during and after treatment with QUTENZA
timeFrame: From Baseline to End of Study (up to 24 months)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Site 103 Abteilung für Anästhesiologie und Intensivmedizin LKH Hartberg
city: Graz
country: Austria
facility: Site 107 Interdisziplinäre Schmerzambulanz Univ. Klinik f. Anästhesiologie und Intensivmedizin Graz, Auenbruggerplatz 29
city: Hartberg
country: Austria
facility: Site 104 Abteilung für Anästhesie und allgemeine Intensivmedizin Allgemein öffentliches Klinikum-Klagenfurt am Wörthersee St. Veiter Strasse 47
city: Klagenfurt am Wörthersee
country: Austria
facility: Site 105 Abteilung für Anästhesiologie und operative Intensivmedizin Allgemeines Krankenhaus Linz Krankenhausstraße 9
city: Linz
country: Austria
facility: Site 106 Interdisziplinäre Schmerzambulanz Univ. Klinik f. Anästhesiologie und Intensivmedizin Graz Auenbruggerplatz 29
city: Vienna
country: Austria
facility: Site 102 Krankenhaus der Elisabethinen GmbH Abteilung für Anästhesie und Intensivmedizin Elisabethinergasse 14
city: Vienna
country: Austria
facility: Site 101 Krankenhaus der Barmherzigen Brüder Abteilung für Anästhesiologie, Intensivmedizin und Schmerztherapie Johannes von Gott Platz 1
city: Athens
country: Greece
facility: Site 202 Antonios Tavernarakis General Hospital of Athens ''Evangelismos'' - Neurology Clinic
state: Attica
city: Athens
country: Greece
facility: Site 206 Dimosthenis Mitsikostas Hellenic Navy Hospital of Athens - Neurology Clinic
state: Attica
city: Athens
country: Greece
facility: Site 205 Antonios Kodounis 251 General Airforce Hospital of Athens - Neurology Clinic
state: Attica
city: Athens
country: Greece
facility: Site 209 Grigorios Panagopoulos- General Hospital of Athens ''G.Gennimatas'' - Neurology Clinic
state: Attica
city: Athens
country: Greece
facility: Site 211 Panagiotis Kokotis Aeginitio University Hospital of Athens - A' Neurology Clinic
state: Attica
city: Athens
country: Greece
facility: Site 213 Mediterraneo Hospital
city: Attica
country: Greece
facility: Site 210 General Hospital of Athens ''G.Gennimatas'' - Neurology Clinic, Athens
city: Larisa
country: Greece
facility: Site 208 Alexandros Papadimitriou University General Hospital of Larisa - Neurology Clinic
city: Thessaloniki
country: Greece
facility: Site 203 Georgios Georgiadis General Hospital of Thessaloniki ''Ippokratio'' - Neurology Clinic
city: Thessaloniki
country: Greece
facility: Site 204 Nikolaos Vlaikidis General Hospital of Thessaloniki ''G.Papanikolaou'' - 3rd Neurology Clinic
city: Thiva
country: Greece
facility: Site 212 2 Pindarou and Tseva Str, Koumerki
city: Aosta
country: Italy
facility: Site 306 Ospedale regionale "Umberto Parini"
state: AO
city: Bari
country: Italy
facility: Site 305 Azienda Ospedaliero-Universitaria Consorziale Policlinico
state: BA
city: Bergamo
country: Italy
facility: Site 308 Spedali Riuniti di Bergamo
state: BG
city: Brescia
country: Italy
facility: Site 301 A.O. Spedali Civili di Brescia
state: BS
city: Pozzilli
country: Italy
facility: Site 303 L'INM Neuromed, Istituto Neurologico Mediterraneo
state: IS
city: Borgo Maggiore
country: Italy
facility: Site 302 Ospedale di Stato della Repubblica di San Marino
state: RSM
city: Taranto
country: Italy
facility: Site 304 Ospedale SS. Annunziata
state: TA
city: Acores
country: Portugal
facility: Site 608 Hospital Divino Espirito Santo, E.P.E.
city: Almada
country: Portugal
facility: Site 607 Hospital Garcia da Orta
city: Amadora
country: Portugal
facility: Site 602 Hospital Professor Dr. Fernando da Fonseca
city: Aveiro
country: Portugal
facility: Site 603 Hospital Infante D. Pedro EPE
city: Covilhã
country: Portugal
facility: Site 611 Centro Hospitalar Cova da Beira - Hospital Universitário Quinta do Alvito
city: Faro
country: Portugal
facility: Site 609 Hospital de Faro
city: Lisbon
country: Portugal
facility: Site 601 Centro Hospitalar Lisboa Norte- Hospital Santa Maria
city: Madeira
country: Portugal
facility: Site 605 Hospital S. João da Madeira
city: Porto
country: Portugal
facility: Site 606 Centro Hospitalar do Porto-Hospital Santo António
city: Porto
country: Portugal
facility: Site 604 Hospital São João
city: Viseu
country: Portugal
facility: Site 610 Hospital S. Teotónio
city: Badalona
country: Spain
facility: Site 702 Hospital Municipal de Badalona
state: Barcelona
city: Bilbao
country: Spain
facility: Site 704 Hospital de Basurto
state: Vizcaya
city: Galdakano
country: Spain
facility: Site 707 Hospital de Galdakano
state: Vizcaya
city: Barcelona
country: Spain
facility: Site 703 Fundació Puigvert
city: Barcelona
country: Spain
facility: Site 705 Hospital Clinic
city: Pamplona
country: Spain
facility: Site 706 Complejo Hospitalario de Navarra
city: Pamplona
country: Spain
facility: Site 708 Clínica Universitaria de Navarra
city: Basel
country: Switzerland
facility: Site 902 Leiter der Schmerzklinik Bethesda-Spital Gellertstrasse 144
city: Saint Gallen
country: Switzerland
facility: Site 901 Schmerzzentrum St. Gallen Kantonspital St.Gallen
city: Whitehaven
country: United Kingdom
facility: Site 802 West Cumberland General Hospital
state: Cumbria
city: Edinburgh
country: United Kingdom
facility: Site 804 Royal Infirmary of Edinburgh
city: Edinburgh
country: United Kingdom
facility: Site 803 Western General Hospital
city: London
country: United Kingdom
facility: Site 801 Chelsea and Westminster Hospital
city: St Martins
country: United Kingdom
facility: Site 805 Princess Elizabeth Hospital
Study officials:
affiliation: Astellas Pharma Europe Ltd.
name: Company Medical Expert
role: STUDY_DIRECTOR
References:
citation: 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.