Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120120
Status:
COMPLETED
Last Update Posted:
2009-09-23
First Post:
2005-07-08
Brief Title:
Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Painful Lumbar Radiculopathy
Sponsor:
Celgene Corporation
Organization:
Celgene
Study Overview
Official Title:
A Multicenter Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Painful Lumbar Radiculopathy
Status:
COMPLETED
Status Verified Date:
2009-09
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 multicenter double-blind placebo-controlled study is to evaluate the efficacy and safety of lenalidomide in the treatment of painful lumbar radiculopathy
Detailed Description:
Study Duration Pre-randomization Phase 14 days Treatment Phase 12 weeks Extension Phase Ongoing Total Study Duration Up to 14 weeks the duration of the extension phase
For each subject the study consists of three phases Pre-randomization phase 14 days Treatment Phase 12 weeks and an extension phase where subjects have the opportunity to receive lenalidomide treatment as long as benefit is derived from the drug Subjects who complete all 12 weeks of the treatment phase may be eligible to initiate subjects randomized to receive placebo in the treatment phase or continue to receive lenalidomide therapy subjects randomized to receive lenalidomide in the treatment phase in the extension phase Subjects may continue in the extension phase as long as a benefit is derived from the drug
For each subject the study consists of three phases Pre-randomization phase 14 days Treatment Phase 12 weeks and an extension phase where subjects have the opportunity to receive lenalidomide treatment as long as benefit is derived from the drug Subjects who complete all 12 weeks of the treatment phase may be eligible to initiate subjects randomized to receive placebo in the treatment phase or continue to receive lenalidomide therapy subjects randomized to receive lenalidomide in the treatment phase in the extension phase Subjects may continue in the extension phase as long as a benefit is derived from the drug
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