NCT00266214

Safety and Efficacy of Lidoderm (Lidocaine Patch 5%) in Treating Moderate to Severe Pain Associated With Carpal Tunnel Syndrome

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (CTS)as 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 (i.e., 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.

Conditions

• Carpal Tunnel Syndrome

Interventions

Type	Name	Description
DRUG	lidocaine patch 5%	1 patch applied topically to the volar aspect of each affected wrist daily, 2-4 hours before bedtime

Timeline

• Start date: 2005-11-01
• Primary completion: 2007-01-01
• Completion: 2007-01-01
• First posted: 2005-12-16
• Last updated: 2011-06-14

Locations

1 site across 1 country: United States