Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475904
Status:
COMPLETED
Last Update Posted:
2011-07-27
First Post:
2007-05-17
Brief Title:
A Comparison of EpiCept NP-1 Topical Cream vs Oral Gabapentin in Postherpetic Neuralgia PHN
Sponsor:
EpiCept Corporation
Organization:
EpiCept Corporation
Study Overview
Official Title:
A Phase II Double-Blind Randomized Placebo-Controlled Non-inferiority Trial of EpiCept NP-1 Topical Cream 2 Ketamine 4 Amitriptyline vs Oral Gabapentin in Postherpetic Neuralgia PHN
Status:
COMPLETED
Status Verified Date:
2011-07
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:
None
Brief Summary:
The purpose of this study is to compare EpiCept NP-1 Topical Cream 2 ketamine 4 amitriptyline vs Oral Gabapentin in the treatment of Postherpetic Neuralgia PHN
Detailed Description:
This is a phase II multicenter double-blind randomized placebo-controlled parallel group study of NP-1 and oral gabapentin in approximately 500 patients with PHN Adult patients with pain resulting from PHN and meeting all other eligibility requirements will be screened for 7 days to determine their average daily pain intensity Qualifying patients will be randomized on a 221 basis to NP-1 oral gabapentin or placebo The treatment period will be 4-Weeks
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