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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00266214
Recruitment Status : Terminated (Sponsor decision)
First Posted : December 16, 2005
Last Update Posted : June 14, 2011
Information provided by:
Endo Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Drug: lidocaine patch 5% Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : November 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Arm Intervention/treatment
Experimental: Lidocaine Patch 5%
1 patch applied topically to the volar aspect of each affected wrist daily, 2-4 hours before bedtime.
Drug: lidocaine patch 5%
1 patch applied topically to the volar aspect of each affected wrist daily, 2-4 hours before bedtime
Other Name: Lidoderm

Placebo Comparator: Placebo
1 patch applied topically to the volar aspect of each affected wrist daily, 2-4 hours before bedtime.
Drug: lidocaine patch 5%
1 patch applied topically to the volar aspect of each affected wrist daily, 2-4 hours before bedtime
Other Name: Lidoderm

Primary Outcome Measures :
  1. Worst daily pain intensity score [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. Average daily pain intensity score [ Time Frame: Week 8 ]
  2. Levine CTS Symptom Severity and Functional Status Scales [ Time Frame: Week 8 ]
  3. Mean interference with daily activities [ Time Frame: Week 8 ]
  4. Intensity of Various Pain Qualities [ Time Frame: Week 8 ]
  5. Quality of Sleep [ Time Frame: Week 8 ]
  6. Global Assessment of Treatment Satisfaction and Impression of Change [ Time Frame: Week 8 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00266214

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United States, Texas
Austin, Texas, United States, 78704
Sponsors and Collaborators
Endo Pharmaceuticals
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Study Director: PPD PPD
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Responsible Party: Endo Clinical Trials Response Center, Endo Pharmaceuticals Identifier: NCT00266214    
Other Study ID Numbers: EN3272-301
First Posted: December 16, 2005    Key Record Dates
Last Update Posted: June 14, 2011
Last Verified: June 2011
Keywords provided by Endo Pharmaceuticals:
lidocaine patch 5%
carpal tunnel syndrome
nerve compression injury
topical analgesic
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Pathologic Processes
Median Neuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action