An observational study in Peripheral Neuropathic Pain, sponsored by Astellas Pharma Europe Ltd.. Completed at 50 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-10-06.
Sponsored by Astellas Pharma Europe Ltd. · Observational
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.
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.
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's enrollment of 429 is above the median of 100 across 260 observational studies indexed under Neuralgia.
Browse Neuralgia studies →Astellas Pharma Europe Ltd. is the lead sponsor of 30 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients receiving QUTENZA for PNP in routine clinical practice
Exclusion Criteria:
Patients with Peripheral Neuropathic Pain
Drug: Qutenza exposure
Cutaneous patch
Also known as: Capsaicin
Percent change in average pain NPRS (Numeric Pain Rating Scale) scores
Time frame: 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)
Time frame: Between 1st & 2nd treatments (up to a maximum of 24 months)
Proportion of patients achieving 30% decrease in average pain NPRS score
Time frame: 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
Time frame: From Baseline to mean of all scores recorded between weeks 2 & 8 following 1st treatment
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)
Time frame: 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 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)
Time frame: 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 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)
Time frame: From Baseline to the mean of all scores between week 2 and week 8 and between week 2 and week 12 following retreatment(s)
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)
Time frame: From baseline to the average of pain scores assessed between Weeks 2 & 12 following 1st and subsequent treatment(s)
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)
Time frame: From baseline to the average of pain scores assessed between Weeks 2 & 12 following 1st and subsequent treatment(s)
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)
Time frame: At each time point following 1st and subsequent treatment(s) (up to a maximum of 24 months)
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)
Time frame: Between successive retreatments (up to a maximum of 24 months)
Number of QUTENZA patches used with each treatment
Time frame: Day 1 of each treatment
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)
Time frame: At first treatment and each retreatment (up to a maximum of 24 months)
Change in concomitant pain medications
Percentage remaining on opioids, anticonvulsants, antidepressants
Time frame: From baseline to End of Study (up to 24 months)
Change in health-related quality of life
Measured by the EQ-5D (Euroqol-5 dimensions) index
Time frame: From baseline to End of Study (up to 24 months)
Change in health resource use
Number of contacts with health professionals in prior 4 weeks
Time frame: From baseline to End of Study (up to 24 months)
Patient Global Impression of Change
Percentage reporting any degree of improvement. Week 2 after 1st Treatment to End of Study
Time frame: At each follow-up after 1st and subsequent treatment(s) (up to a maximum of 24 months)
Patient Self Assessment of Treatment
Week 2 after 1st Treatment to End of Study
Time frame: At 12 weeks, 6 months, 9 months, and 12 months after 1st and subsequent retreatment(s)
Change in Work Productivity and Activity Impairment scores
Week 2 after 1st Treatment to End of Study
Time frame: Baseline, week 12, 6 months, 9 months, and 12 months after 1st and subsequent treatment(s)
Percentage of patients requiring rescue measures during and after treatment with QUTENZA
Time frame: From Baseline to End of Study (up to 24 months)
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Astellas Pharma Europe Ltd.