NCT00904475

Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain

A Prospective, Prospective, Double-blind, Randomized, Placebo-Controlled, Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with moderate to severe chronic Low Back Pain (LBP) despite current analgesic treatment participated in a Phase IV clinical trial to evaluate the analgesic efficacy of the lidocaine patch 5% compared to placebo in treating moderate to severe chronic LBP.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
DRUG	Lidoderm®	Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h.
DRUG	Lidoderm®	Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h.

Timeline

• Start date: 2003-04-01
• Primary completion: 2003-04-01
• First posted: 2009-05-19
• Last updated: 2010-02-15

Locations

6 sites across 1 country: United States