NCT00904397

Lidocaine Patch 5% Versus Celecoxib 200 mg in Chronic Axial Low Back Pain

A Randomized, Open-Label Study Comparing the Efficacy and Safety of Lidocaine Patch 5% With Celecoxib 200 mg in Patients With Chronic Axial Low Back Pain

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients who had axial lower back pain (LBP) with or without radiation present for at least 3 months and had daily moderate to severe LBP as the primary source of pain participated in a Phase IV clinical trial to assess the efficacy of lidocaine patch 5% compared to celecoxib 200 mg in treating chronic axial LBP with and without radiation.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
DRUG	Lidoderm®	Patients participated in a 14-day washout period followed by a 12-week active treatment period. Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or celecoxib 200 mg.
DRUG	Celecoxib	Patients participated in a 14-day washout period followed by a 12-week active treatment period. Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or celecoxib 200 mg.

Timeline

• Start date: 2004-07-01
• Primary completion: 2004-11-01
• First posted: 2009-05-19
• Last updated: 2010-02-15

Locations

21 sites across 1 country: United States