Observation of the Use of QUTENZA™ in Standard Clinical Practice

Peripheral Neuropathic Pain Clinical Trial

— ASCEND  

Official title:

The Use of QUTENZA™ in Standard Clinical Practice: a Phase IV, Multicentre, European Non-interventional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01737294
• Other study ID #: QTZ-EC-0003
• Status: Completed
• Phase: N/A
• First received: October 22, 2012
• Last updated: October 3, 2014
• Start date: February 2012
• Est. completion date: August 2014

Study information

• Verified date: October 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Scientific and Medical Research Council Ethics CommitteeItaly: Ethics CommitteeGreece: Ethics CommitteePortugal: Health Ethic CommitteeUnited Kingdom: Research Ethics CommitteeSpain: Departament de Salut de la Generalitat de CatalunyaSwitzerland: EthikkommissionAustria: Agency for Health and Food Safety
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 429
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Neuralgia
• Peripheral Neuropathic Pain

Intervention

Drug:
• Qutenza exposure
Cutaneous patch

Locations

Country	Name	City	State
Austria	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 am Wörthersee
Austria	Site 106 Interdisziplinäre Schmerzambulanz Univ. Klinik f. Anästhesiologie und Intensivmedizin Graz Auenbruggerplatz 29	Linz
Austria	Site 101 Krankenhaus der Barmherzigen Brüder Abteilung für Anästhesiologie, Intensivmedizin und Schmerztherapie Johannes von Gott Platz 1	Vienna
Austria	Site 102 Krankenhaus der Elisabethinen GmbH Abteilung für Anästhesie und Intensivmedizin Elisabethinergasse 14	Vienna
Greece	Site 202 Antonios Tavernarakis General Hospital of Athens ''Evangelismos'' - Neurology Clinic	Athens	Attica
Greece	Site 205 Antonios Kodounis 251 General Airforce Hospital of Athens - Neurology Clinic	Athens	Attica
Greece	Site 206 Dimosthenis Mitsikostas Hellenic Navy 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 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 203 Georgios Georgiadis General Hospital of Thessaloniki ''Ippokratio'' - Neurology Clinic	Thessaloniki
Greece	Site 204 Nikolaos Vlaikidis General Hospital of Thessaloniki ''G.Papanikolaou'' - 3rd Neurology Clinic	Thessaloniki
Greece	Site 212 2 Pindarou and Tseva Str, Koumerki	Thiva
Italy	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 302 Ospedale di Stato della Repubblica di San Marino	Borgo Maggiore	RSM
Italy	Site 301 A.O. Spedali Civili di Brescia	Brescia	BS
Italy	Site 303 L'INM Neuromed, Istituto Neurologico Mediterraneo	Pozzilli	IS
Italy	Site 304 Ospedale SS. Annunziata	Taranto	TA
Portugal	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 611 Centro Hospitalar Cova da Beira - Hospital Universitário Quinta do Alvito	Covilhã
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	Madeira
Portugal	Site 604 Hospital São João	Porto
Portugal	Site 606 Centro Hospitalar do Porto-Hospital Santo António	Porto
Portugal	Site 610 Hospital S. Teotónio	Viseu
Spain	Site 702 Hospital Municipal de Badalona	Badalona	Barcelona
Spain	Site 703 Fundació Puigvert	Barcelona
Spain	Site 705 Hospital Clinic	Barcelona
Spain	Site 704 Hospital de Basurto	Bilbao	Vizcaya
Spain	Site 707 Hospital de Galdakano	Galdakano	Vizcaya
Spain	Site 706 Complejo Hospitalario de Navarra	Pamplona
Spain	Site 708 Clínica Universitaria de Navarra	Pamplona
Switzerland	Site 902 Leiter der Schmerzklinik Bethesda-Spital Gellertstrasse 144	Basel
Switzerland	Site 901 Schmerzzentrum St. Gallen Kantonspital St.Gallen	Saint Gallen
United Kingdom	Site 803 Western General Hospital	Edinburgh
United Kingdom	Site 804 Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Site 801 Chelsea and Westminster Hospital	London
United Kingdom	Site 805 Princess Elizabeth Hospital	St Martins
United Kingdom	Site 802 West Cumberland General Hospital	Whitehaven	Cumbria

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Europe Ltd.

Countries where clinical trial is conducted

Austria,  Greece,  Italy,  Portugal,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	Percent change in "average pain" NPRS score	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)	From baseline to mean of all scores between Week 2 and Week 8 and Weeks 2 and Week 12 following retreatment(s)	No
Secondary	Proportion of patients achieving a 30% decrease in their "average pain" NPRS score (maintenance response)	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)	From Baseline to the mean of all scores between week 2 and week 8 and between week 2 and week 12 following retreatment(s)	No
Secondary	Proportion of patients achieving a 50% decrease in their "average pain" NPRS score (maintenance response)	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)	From Baseline to the mean of all scores between week 2 and week 8 and between week 2 and week 12 following retreatment(s)	No
Secondary	Absolute change in "average pain" NPRS score	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)	From baseline to the average of pain scores assessed between Weeks 2 & 12 following 1st and subsequent treatment(s)	No
Secondary	Proportion of patients achieving a 2-point absolute decrease in their "average pain" NPRS score	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)	From baseline to the average of pain scores assessed between Weeks 2 & 12 following 1st and subsequent treatment(s)	No
Secondary	Mean "Average pain" NPRS score	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)	At each time point following 1st and subsequent treatment(s) (up to a maximum of 24 months)	No
Secondary	Time (in days) between successive retreatments	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 successive retreatments (up to a maximum of 24 months)	No
Secondary	Number of QUTENZA patches used with each treatment		Day 1 of each treatment	No
Secondary	Relative change in treatment area size	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)	At first treatment and each retreatment (up to a maximum of 24 months)	No
Secondary	Change in concomitant pain medications	Percentage remaining on opioids, anticonvulsants, antidepressants	From baseline to End of Study (up to 24 months)	No
Secondary	Change in health-related quality of life	Measured by the EQ-5D (Euroqol-5 dimensions) index	From baseline to End of Study (up to 24 months)	No
Secondary	Change in health resource use	Number of contacts with health professionals in prior 4 weeks	From baseline to End of Study (up to 24 months)	No
Secondary	Patient Global Impression of Change	Percentage reporting any degree of improvement. Week 2 after 1st Treatment to End of Study	At each follow-up after 1st and subsequent treatment(s) (up to a maximum of 24 months)	No
Secondary	Patient Self Assessment of Treatment	Week 2 after 1st Treatment to End of Study	At 12 weeks, 6 months, 9 months, and 12 months after 1st and subsequent retreatment(s)	No
Secondary	Change in Work Productivity and Activity Impairment scores	Week 2 after 1st Treatment to End of Study	Baseline, week 12, 6 months, 9 months, and 12 months after 1st and subsequent treatment(s)	No
Secondary	Percentage of patients requiring rescue measures during and after treatment with QUTENZA		From Baseline to End of Study (up to 24 months)	No