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

NCT00266214 | Terminated Phase 3

• 1 other identifier: EN3272-301
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

lidocaine patch 5%; Lidoderm; carpal tunnel syndrome; pain; nerve compression injury; topical analgesic

Outcome Measures

Primary Outcomes (1)

• Worst daily pain intensity score

  Week 8

Secondary Outcomes (6)

• Average daily pain intensity score

  Week 8

• Levine CTS Symptom Severity and Functional Status Scales

  Week 8

• Mean interference with daily activities

  Week 8

• Intensity of Various Pain Qualities

  Week 8

• Quality of Sleep

  Week 8

Study Arms (2)

Lidocaine Patch 5%

EXPERIMENTAL

1 patch applied topically to the volar aspect of each affected wrist daily, 2-4 hours before bedtime.

Drug: lidocaine patch 5%

Placebo

PLACEBO COMPARATOR

1 patch applied topically to the volar aspect of each affected wrist daily, 2-4 hours before bedtime.

Drug: lidocaine patch 5%

Interventions

lidocaine patch 5% DRUG

1 patch applied topically to the volar aspect of each affected wrist daily, 2-4 hours before bedtime

Also known as: Lidoderm

Lidocaine Patch 5%; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (1)

PPD

Austin, Texas, 78704, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Pain; Neuroma

Interventions

Lidoderm

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• PPD

  PPD Development, LP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 15, 2005
• First Posted: December 16, 2005
• Study Start: November 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: June 14, 2011

Record last verified: 2011-06

Locations

US (1)