Safety and Efficacy of Lidoderm (Lidocaine Patch 5%) in Treating Moderate to Severe Pain Associated With Carpal Tunnel Syndrome

Exclusion Criteria

• •Have a positive serum pregnancy test (females of childbearing potential only)
• •Have tumors or cysts in the wrist, muscle wasting in the forearm and/or hand, peripheral neuropathy, mononeuropathy multiplex, or hand arthritis
• •Have had previous CTS surgery
• •Have severe CTS as defined by electrodiagnostic findings
• •Have had steroid injections for CTS in the previous 3 months
• •Have used diuretics (except a stable dose for hypertension) or Vitamin B6 or topical treatments for CTS (e.g., ultrasound, iontophoresis, cold laser) in the past 2 weeks
• •Require sleep medications
• •Are using a lidocaine-containing product that cannot be discontinued during the study
• •Have a known sensitivity or allergy to an amide-type local anesthetic agent para-aminobenzoic (PABA) derivatives or local anesthetics
• •Have previously participated in a Lidoderm study
• •Have severe renal insufficiency (creatinine clearance of \<30 mL/min)
• •Have moderate or greater hepatic impairment, including a history of or active hepatitis
• •Have abnormal clinical laboratory test results unless deemed clinically insignificant by the investigator
• •Have current or planned litigation, or who are planning to acquire or are currently receiving Worker's Compensation or Social Security benefits, or who, in the opinion of the investigator, exhibit any evidence of secondary gain (monetary or non-monetary) associated with carpal tunnel syndrome pain.
• •Have a history of alcohol or substance abuse within the last 3 years
• •Have received an investigational drug or product or participated in an investigational drug study within a period of 30 days or 5 half-lives prior to receiving study drug