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www.fdanews.com/articles/80967-adolor-begins-trial-for-sterile-lidocaine-patch

ADOLOR BEGINS TRIAL FOR STERILE LIDOCAINE PATCH

September 16, 2005

Adolor has initiated Study 29CL227, a Phase II clinical trial of its sterile lidocaine patch intended for the treatment of postsurgical incisional pain.

Adolor's lidocaine patch is a sterile patch containing a concentration of sustained-release lidocaine. Under the protocol, investigators apply the patch directly over the incision upon closing and leave the patch in place for 72 hours. The patch is intended for use in both hospital and outpatient surgical settings.

Study 29CL227 is a double-blind, placebo-controlled, randomized, multicenter study of a sterile lidocaine patch enrolling 30 patients undergoing hernia repair surgery. The study's primary objective is to evaluate the pharmacokinetics of this investigational new product. Safety and tolerability will be evaluated for up to 72 hours, and preliminary efficacy data will be obtained to assess the analgesic effect during the 72-hour treatment period, as demonstrated by a reduction in pain scores measured by the 11-point Numeric Pain Rating Scale.