Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT01737294
Status:
COMPLETED
Last Update Posted:
2014-10-06
First Post:
2012-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observation of the Use of QUTENZA™ in Standard Clinical Practice
Sponsor:
Astellas Pharma Europe Ltd.
Organization:
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 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.
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.
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:
False
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?: