Observation of the Use of QUTENZA™ in Standard Clinical Practice

Completed

• Conditions: Peripheral Neuropathic Pain
• Interventions: Drug: Qutenza exposure

• 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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-10-22
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-29
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-03
• Last Update Posted: 2014-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 429

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

• 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 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 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

Scroll for more (40 remaining)