A Study Comparing The Efficacy And Safety Of Lidocaine 5% Patch With Placebo In Patients With Chronic Axial Low Back Pain

A Randomized, Double-blind Study Comparing The Efficacy And Safety Of Lidocaine 5% Patch With Placebo In Patients With Chronic Axial Low Back Pain

Patients with Chronic Axial Low Back Pain participated in a Phase II clinical trial to assess the efficacy of lidocaine 5% patch compared with placebo.

Study Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Drug: Lidoderm®; Drug: Placebo Topical Patch

• Study Type: Interventional
• Enrollment (Actual): 215
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
  • Arizona
    • Phoenix, Arizona, United States
  • California
    • Carlsbad, California, United States
    • National City, California, United States
  • Connecticut
    • Waterbury, Connecticut, United States
  • District of Columbia
    • Washington, District of Columbia, United States
  • Florida
    • Port Orange, Florida, United States
  • Georgia
    • Atlanta, Georgia, United States
  • Illinois
    • Chicago, Illinois, United States
  • Kansas
    • Overland Park, Kansas, United States
  • Massachusetts
    • Pittsfield, Massachusetts, United States
  • North Carolina
    • Burlington, North Carolina, United States
  • Pennsylvania
    • Altoona, Pennsylvania, United States
    • Duncansville, Pennsylvania, United States
    • Philadelphia, Pennsylvania, United States
  • Tennessee
    • Cordova, Tennessee, United States
  • Texas
    • San Antonio, Texas, United States
  • Virginia
    • Virginia Beach, Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Had axial LBP with or without radiation present for at least 3 months as defined as:

  • Chronic axial LBP without radiation: pain isolated to the axial low back without radiation into the buttock or below
  • Chronic axial LBP with radiation: pain that radiates to the buttock or below. This patient group could include patients with radicular/neuropathic and non-radicular components with leg pain component <50%
• Had daily moderate to severe LBP as the primary source of pain

• Had a normal neurological examination, including:

  • Motor strength
  • Sensory exam in lower extremities
  • Deep tendon reflexes
• Had a normal 12-lead electrocardiogram (ECG) without any clinically significant abnormalities in heart rate, rhythm, or conduction
• Had discontinued use of all analgesic medications (including over-the-counter [OTC] analgesics) prior to randomization (patients were allowed limited use of analgesic medications for indications other than non-study pain).
• Had a daily average pain intensity rating of 6 or greater (on a 0 to 10 scale) for at least 3 days out of the 5 consecutive days immediately prior to the baseline visit; 0 was defined as "no pain" and 10 was defined as "pain as bad as ever imagined" as measured by Question 5 of the Brief Pain Inventory (BPI) and recorded in a diary

Key Exclusion Criteria:

• Had spinal stenosis with > 50% leg pain component
• Had elective surgery scheduled to occur during the 14-week study
• Had a history of one or more back surgeries within 1 year of study entry
• Had severe renal insufficiency (creatinine clearance of <30mL/min)
• Had moderate or greater hepatic impairment
• Were taking analgesic medications that could not be discontinued during the study. Patients taking these medications prior to the study were required to discontinue use for the duration of the study. Patients using opioid analgesics at study entry were required to taper off these medications.
• Were taking long-acting opioids or opioids that could not be discontinued over the first 5 days of the placebo run-in period
• Had received an epidural steroid/local anesthesia injection within 4 weeks prior to study entry
• Had received trigger point injections within 2 weeks prior to study entry
• Had received Botulinum Toxin (Botox) Injections for LBP within 6 months prior to study entry
• Were using a lidocaine-containing product that could not be discontinued during the study
• Were using any topical medication applied to the low back region
• Had previously failed treatment with Lidoderm analgesic patch for LBP
• Were taking class 1 anti-arrhythmic drugs (e.g. mexiletine, tocainide)
• Had any other chronic pain condition that, in the opinion of the investigator, would have interfered with patient assessment of LBP relief

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine 5% Patch; Lidocaine 5% patch (Lidoderm®,Endo Pharmaceuticals Inc.), 2 patches applied directly to the most painful area of the low back once daily (q24h)	Drug: Lidoderm®; Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.; Other Names: Lidocaine 5% Patch
Placebo Comparator: Placebo Topical Patch; Matching placebo patch, 2 patches applied directly to the most painful area of the low back once daily (q24h)	Drug: Placebo Topical Patch; Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain intensity (Question 5 of the BPI)	Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84)

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety Assessments included AEs, dermal assessments, clinical laboratory results (including urinalysis), vital sign measurements, physical and neurological examinations, plasma lidocaine concentration	Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84)

Collaborators and Investigators

• Sponsor: Endo Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): October 1, 2005

Study Registration Dates

• First Submitted: May 15, 2009
• First Submitted That Met QC Criteria: May 18, 2009
• First Posted (Estimate): May 19, 2009

Study Record Updates

• Last Update Posted (Estimate): December 6, 2013
• Last Update Submitted That Met QC Criteria: December 5, 2013
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: EN3261-001