Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 12:26 AM
Study NCT ID:
NCT01252160
Status:
COMPLETED
Last Update Posted:
2018-04-19
First Post:
2010-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness of Repeated Administration of QUTENZA Patches for Treatment of Pain Caused by Nerve Damage
Sponsor:
Astellas Pharma Inc
Organization:
Study Overview
Official Title:
A Multicentre, Single-Arm, Open-Label Study Of The Repeated Administration Of QUTENZA For The Treatment Of Peripheral Neuropathic Pain
Status:
COMPLETED
Status Verified Date:
2018-04
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:
STRIDE
Brief Summary:
In this study all patients will be treated with the same medicine, the QUTENZA patch. Subjects will receive up to 6 QUTENZA patch applications over 12 months.
Detailed Description:
The rationale for the current study is to evaluate the safety of repeated QUTENZA applications, including the effect of QUTENZA on sensory function in subjects diagnosed with different types of Peripheral Neuropathic Pain (PNP). In order to adequately assess the long-term safety QUTENZA in well defined patient populations the current study will enroll a minimum of 100 patients each with HIV-Associated Neuropathy (HIV-AN) and Postherpetic Neuralgia (PHN).
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2009-016457-18 | EUDRACT_NUMBER | None | View |