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

Carpal Tunnel Syndrome Clinical Trial

Official title:

A Randomized, Double-Blind Study Comparing the Safety and Efficacy of the Lidocaine Patch 5% With Placebo in Patients With Pain From Carpal Tunnel Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00266214
• Other study ID #: EN3272-301
• Status: Terminated
• Phase: Phase 3
• First received: December 15, 2005
• Last updated: June 13, 2011
• Start date: November 2005
• Est. completion date: January 2007

Study information

• Verified date: June 2011
• Source: Endo Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Patients with carpal tunnel syndrome (CTS)as determined by electrodiagnostic testing and moderate to severe pain will be randomized to receive either the lidocaine patch 5% or placebo patch q24h. The total duration of the double-blind treatment phase of the study will be 8 weeks.

At baseline and at periodic visits to the clinic, patients will perform pain and functionality assessments. Patients with bilateral CTS will identify the "index" wrist (i.e., the more painful wrist), which will subsequently be the wrist used for all efficacy assessments throughout the study.

Treatment Regimen and Route of Administration: Patients will apply one patch (either a lidocaine patch 5% or a matching placebo patch) to the volar aspect of each affected wrist once every 24 hours.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 210
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Drug:
• lidocaine patch 5%
1 patch applied topically to the volar aspect of each affected wrist daily, 2-4 hours before bedtime

Locations

Country	Name	City	State
United States	PPD	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Worst daily pain intensity score		Week 8	No
Secondary	Average daily pain intensity score		Week 8	No
Secondary	Levine CTS Symptom Severity and Functional Status Scales		Week 8	No
Secondary	Mean interference with daily activities		Week 8	No
Secondary	Intensity of Various Pain Qualities		Week 8	No
Secondary	Quality of Sleep		Week 8	No
Secondary	Global Assessment of Treatment Satisfaction and Impression of Change		Week 8	No