Ignite Creation Date:
2024-05-06 @ 1:08 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01737294
Status:
COMPLETED
Last Update Posted:
2014-10-06
First Post:
2012-10-22
Brief Title:
Observation of the Use of QUTENZA in Standard Clinical Practice
Sponsor:
Astellas Pharma Europe Ltd
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
The Use of QUTENZA in Standard Clinical Practice a Phase IV Multicentre European Non-interventional Study
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASCEND
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 patients 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
The patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None