Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00099528
Status:
UNKNOWN
Last Update Posted:
2010-07-29
First Post:
2004-12-15
Brief Title:
Dose-Finding Study of REN-1654 in Patients With Post-Herpetic Neuralgia
Sponsor:
Renovis
Organization:
Renovis
Study Overview
Official Title:
REN-1654 in Post-Herpetic Neuralgia a Multi-Center Placebo Controlled 3-week Dose-Finding Study With a 3-Week Active-Treatment Extension
Status:
UNKNOWN
Status Verified Date:
2005-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to gain initial safety and efficacy data on the experimental agent REN-1654 in patients with painful post-herpetic neuralgia PHN
Detailed Description:
This is a multi-center double-blind randomized placebo-controlled dose-finding study After screening and baseline clinical assessments subjects will be randomly assigned to receive 30 or 100 mg REN-1654 by mouth po or matching placebo once daily for 3 weeks After 3 weeks of treatment the clinical assessments will be repeated Subjects who complete the 3 week placebo-controlled segment may enter the 3-week active-treatment extension segment during which subjects in the REN-1654 30 mg group will remain on that dose subjects who were given placebo in the previous segment will receive REN-1654 100 mg daily and subjects who received REN 1654 100 mg in the first 3 week study segment will discontinue dosing Double-blind conditions will be maintained through the placebo-controlled active treatment period primary efficacy endpoint and for those continuing dosing into the 3-week second active treatment period The clinical assessments will be repeated at the end of 6 weeks after which all subjects will discontinue treatment and return 2 weeks later for the final clinical assessment
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