Clinical trial: Safety and Efficacy of Lidoderm (Lidocaine Patch 5%) in Treating Moderate to Severe Pain Associated With Carpal Tunnel Syndrome (NCT00266214)

Eligibility 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Contradiction