drugset / Trial / NCT00589979

Efficacy and Safety of the Lidoderm Patch Applied to Patients With Osteoarthritis of the Knee

NCT00589979 ↗

Phase 2 Completed 169 enrolled Endo USA Inc., a Keenova Therapeutics Company
RandomizedCrossoverTriple-blindTreatment

Summary

Patients with knee pain due to Osteoarthritis (OA) experiencing sub-optimal pain relief from their current analgesic regimen will participate in a pilot clinical trial to evaluate the effectiveness and tolerability of the Lidoderm Patch compared with placebo in treating knee pain from OA.

Timeline

Start
2007-03
Primary completion
2008-06
Completion
2008-10

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Sequence: Lidoderm - Placebo - Placebo (LPP) vs Sequence: Placebo - Lidoderm - Lidoderm (PLL); p = 0.1006; Hazard Ratio (HR) 1.78 (95% CI 0.89 to 3.55) NCT00589979 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lidocaine Other / unclassified 5 % Topical

Indications