Ignite Creation Date:
2024-05-06 @ 12:16 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01533428
Status:
COMPLETED
Last Update Posted:
2015-11-04
First Post:
2012-02-12
Brief Title:
A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy PDPN
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase III Double-blind Randomized Placebo-controlled Multicenter Study Evaluating the Efficacy and Safety of QUTENZA in Subjects With Painful Diabetic Peripheral Neuropathy
Status:
COMPLETED
Status Verified Date:
2015-10
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:
STEP
Brief Summary:
The purpose of the study is to assess efficacy and safety of a single treatment of Capsaicin 8 transdermal delivery system in reducing pain from damaged nerves neuropathic pain caused by diabetes
Detailed Description:
Participants were divided into 2 groups of approximately equal size In the first group participants received a Capsaicin 8 patch applied for 30 minutes to the feet in the second group participants received a placebo patch applied for 30 minutes to the feet Participants were involved in the study for approximately 12 weeks and have visited the clinic approximately 6 times
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