NCT00904540

Topical Lidocaine Patch in Low Back Pain

Open-Label Study Assessing the Efficacy of Topical Lidocaine Patch in Treatment of Low Back Pain

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Endo Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with acute or chronic Lower Back Pain (LBP) participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm administered once daily (q24h) for 2 weeks in the treatment of acute and chronic LBP.

Conditions

• Acute and Chronic Non-radicular LBP

Interventions

Type	Name	Description
DRUG	Lidoderm®	Patients participated in a 6-week treatment period. Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain. Patients were stratified into the following groups at enrollment: acute (\<6 weeks) LBP, subacute (6 weeks to \<3 months) LBP, short-term chronic (3 months to 12 months, inclusive) LBP, and long-term chronic (\>12 months LBP)

Timeline

• Start date: 2002-03-01
• Primary completion: 2002-10-01
• First posted: 2009-05-19
• Last updated: 2024-01-02

Locations

7 sites across 1 country: United States