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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Carpal Tunnel Syndrome

In brief

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.

Key facts

Study ID

NCT00266214

Run by

Endo USA Inc., a Keenova Therapeutics Company

People needed

210

Starts

2005-11-01

Expected to finish

2007-01-01

Last updated by the study team

2011-06-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• PPD — Austin, Texas, United States

Full record on ClinicalTrials.gov

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