Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266214
Status:
TERMINATED
Last Update Posted:
2011-06-14
First Post:
2005-12-15
Brief Title:
Safety and Efficacy of Lidoderm Lidocaine Patch 5 in Treating Moderate to Severe Pain Associated With Carpal Tunnel Syndrome
Sponsor:
Endo Pharmaceuticals
Organization:
Endo Pharmaceuticals
Study Overview
Official Title:
A Randomized Double-Blind Study Comparing the Safety and Efficacy of the Lidocaine Patch 5 With Placebo in Patients With Pain From Carpal Tunnel Syndrome
Status:
TERMINATED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
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 evaluate the analgesic efficacy and safety of the lidocaine patch 5 compared to placebo in patients with moderate to severe pain associated with carpal tunnel syndrome
Detailed Description:
Patients with carpal tunnel syndrome CTSas determined by electrodiagnostic testing and moderate to severe pain will be randomized to receive either the lidocaine patch 5 or placebo patch q24h The total duration of the double-blind treatment phase of the study will be 8 weeks
At baseline and at periodic visits to the clinic patients will perform pain and functionality assessments Patients with bilateral CTS will identify the index wrist ie the more painful wrist which will subsequently be the wrist used for all efficacy assessments throughout the study
Treatment Regimen and Route of Administration Patients will apply one patch either a lidocaine patch 5 or a matching placebo patch to the volar aspect of each affected wrist once every 24 hours
At baseline and at periodic visits to the clinic patients will perform pain and functionality assessments Patients with bilateral CTS will identify the index wrist ie the more painful wrist which will subsequently be the wrist used for all efficacy assessments throughout the study
Treatment Regimen and Route of Administration Patients will apply one patch either a lidocaine patch 5 or a matching placebo patch to the volar aspect of each affected wrist once every 24 hours
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