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

This study has been terminated.
(Sponsor decision)
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00266214
First received: December 15, 2005
Last updated: June 13, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention Phase
Carpal Tunnel Syndrome
 Drug: lidocaine patch 5%
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Worst daily pain intensity score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Average daily pain intensity score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Levine CTS Symptom Severity and Functional Status Scales [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Mean interference with daily activities [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Intensity of Various Pain Qualities [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Quality of Sleep [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
  • Global Assessment of Treatment Satisfaction and Impression of Change [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Enrollment: 210
Study Start Date: November 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00266214

Locations
United States, Texas
PPD
Austin, Texas, United States, 78704
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: PPD PPD
  More Information

No publications provided

Responsible Party: Endo Clinical Trials Response Center     , Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00266214     History of Changes
Other Study ID Numbers: EN3272-301
Study First Received: December 15, 2005
Last Updated: June 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Endo Pharmaceuticals:
lidocaine patch 5%
Lidoderm
carpal tunnel syndrome
 pain
nerve compression injury
topical analgesic

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Lidocaine
 Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 22, 2013