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

Carpal Tunnel Syndrome Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

• NCT number: NCT00266214
• Study type: Interventional
• Source: Endo Pharmaceuticals
• Status: Terminated
• Phase: Phase 3
• Start date: November 2005
• Completion date: January 2007