Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107055
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2005-04-04
Brief Title:
Study of REN-1654 in Patients With Sciatica Pain
Sponsor:
Renovis
Organization:
Renovis
Study Overview
Official Title:
REN-1654 in Sciatica A Phase 2 Randomized Double-Blind Placebo Controlled Multi-Center Study in Subjects With Pain Due to Lumbosacral Radiculopathy
Status:
UNKNOWN
Status Verified Date:
2005-06
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 pain that radiates down the legs and is typical of sciatica lumbosacral radiculopathy These patients will usually have a herniated disc that is causing compression on the nerves coming out of the spinal column
Detailed Description:
This is a multi-center randomized double-blind placebo-controlled study to determine the efficacy and tolerability of REN-1654 in subjects with sciatica After screening and baseline clinical assessments subjects will be randomly assigned to receive REN 1654 100 mg or matching placebo once daily for 3 weeks Leg pain back pain and other efficacy measures will be assessed at 1 and 3 weeks after initiation of treatment A subset of patients will undergo analysis of blood levels of REN-1654 during the course of the study pharmacokinetics Subjects will discontinue treatment after 3 weeks and return after a further 3 weeks off therapy for a final clinical assessment 6 weeks after initiation of treatment If a subject does not return for follow-up an effort will be made by telephone to document their clinical status and whether other interventions have been made
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