Overview

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

Status:
Terminated
Trial end date:
2007-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the analgesic efficacy and safety of the lidocaine patch 5% compared to placebo in patients with moderate to severe pain associated with carpal tunnel syndrome.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Endo Pharmaceuticals
Treatments:
Lidocaine
Criteria
Inclusion Criteria:

- Are males or females 18 years of age or older

- Have confirmed diagnosis of CTS in one or both wrists. For patients with bilateral
CTS, the most painful wrist will be identified as the "index" wrist, and will be the
wrist used for all efficacy evaluations.

- Have clinical symptoms of pain, paresthesia, numbness and/or tingling in the
distribution of the median nerve

- Have positive findings from electrodiagnostic tests using accepted criteria

- Have classification of the wrist(s) as "classic" or "probable" using the Katz Hand
Diagram (Katz and Stirrat, 1990)

- Have worst daily pain intensity greater than 5 (0-10 scale) on approximately 75% of
days over the previous 3 months; this criteria will be assessed at the screening visit
only

- Have a normal 12-lead electrocardiogram (ECG) without any clinically significant
abnormalities in heart rate, rhythm, or conduction

- Have been informed of the nature of the study and provided written informed consent

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