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First head-to-head study to compare lidoderm patch and Celebrex in treating pain

l reductions in pain were noted in both treatment groups at week 12.

"Although these results need to be confirmed with further randomized controlled trials, the potential of Lidoderm to treat osteoarthritis knee pain is promising," added Dr. Kivitz. "Lidoderm has been used since 1999 to treat the pain of post-herpetic neuralgia and, because it is a non-systemic patch, has demonstrated a minimal risk of side effects or drug-to-drug interaction. Our hope is to see similar results in further Lidoderm osteoarthritis knee pain studies."

About the Study
The randomized, open-label, active-control, parallel-group study, which was intended to enroll 200 patients, contained data for 143 patients experiencing OA pain of either one or both knees and evaluated efficacy and safety of treatment. After a 7- to 14-day wash-out period during which all analgesic medications, chondroitin, and glucosamine were discontinued, patients with an average daily pain intensity score of =5 on a scale of 0 to 10 for three of five consecutive days and an OA severity score of =7 on a scale of 0 to 24 prior to the baseline visit were randomized to 12 weeks of treatment with either one full Lidoderm patch on the front of the knee and one-third of a patch on the back of each affected knee (69 patients) once daily for 24 hours or Celebrex 200 mg once daily (74 patients). Efficacy measures included the Western Ontario and McMaster Universities OA Index, Brief Pain Index (BPI), Pain Quality Assessment Scale and global assessments of change in OA pain and treatment satisfaction.

In the study, both treatments were well tolerated, with adverse events reported in eight patients in each group. The most common adverse events were itchiness or redness at the patch site. Additionally, three patients in the Lidoderm group discontinued the study due to adverse events. There were no discontinuations due to treatment-related adverse events in the Celebrex gro
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Contact: Fiona Buraimoh
fiona_buraimoh@nyc.cohnwolfe.com
212-798-9512
Cohn & Wolfe
31-Mar-2005


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