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

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00904111
First received: May 15, 2009
Last updated: December 5, 2013
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Chronic Low Back Pain
Drug: Lidoderm®
Drug: Placebo Topical Patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Study Comparing The Efficacy And Safety Of Lidocaine 5% Patch With Placebo In Patients With Chronic Axial Low Back Pain

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Pain intensity (Question 5 of the BPI) [ Time Frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety Assessments included AEs, dermal assessments, clinical laboratory results (including urinalysis), vital sign measurements, physical and neurological examinations, plasma lidocaine concentration [ Time Frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84) ] [ Designated as safety issue: Yes ]

Enrollment: 215
Study Start Date: August 2004
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.
Other Name: Placebo Topical Patch

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904111

Locations
United States, Alabama
Birmingham, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, California
Carlsbad, California, United States
National City, California, United States
United States, Connecticut
Waterbury, Connecticut, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Port Orange, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Kansas
Overland Park, Kansas, United States
United States, Massachusetts
Pittsfield, Massachusetts, United States
United States, North Carolina
Burlington, North Carolina, United States
United States, Pennsylvania
Altoona, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
United States, Tennessee
Cordova, Tennessee, United States
United States, Texas
San Antonio, Texas, United States
United States, Virginia
Virginia Beach, Virginia, United States
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
Study Director: Study Director Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sr. Director, Clinical R&D, Endo Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00904111     History of Changes
Other Study ID Numbers: EN3261-001
Study First Received: May 15, 2009
Last Updated: December 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014