Topical Lidocaine Patch in Low Back Pain

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00904540
First received: May 15, 2009
Last updated: February 8, 2010
Last verified: February 2010
  Purpose

Patients with acute or chronic Lower Back Pain (LBP) participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm administered once daily (q24h) for 2 weeks in the treatment of acute and chronic LBP.


Condition Intervention Phase
Acute and Chronic Non-radicular LBP
Drug: Lidoderm®
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label Study Assessing the Efficacy of Topical Lidocaine Patch in Treatment of Low Back Pain

Resource links provided by NLM:


Further study details as provided by Endo Pharmaceuticals:

Primary Outcome Measures:
  • Mean change in average daily intensity (Question 5 of Brief Pain Inventory [BPI] Questionnaire) from baseline to Week 2 [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline to Week 6 in average pain intensity (Question 5 of the BPI) [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) ] [ Designated as safety issue: No ]
  • Mean change from baseline to Week 2 and to Week 6 in Neuropathic Pain Scale (NPS) composite scores [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) ] [ Designated as safety issue: No ]
  • QOL: change from baseline to Week 2 to Week 6 in Question 9 of the BPI, in Beck Depression Inventory Questionnaire, and the Patient and Investigator Global Assessment of Patch Satisfaction and Pain Relief [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) ] [ Designated as safety issue: No ]
  • Safety assessments include AEs, clinical laboratory tests, vital signs, physical/neurological examinations, and dermal/sensory assessments. [ Time Frame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) ] [ Designated as safety issue: Yes ]

Enrollment: 131
Study Start Date: March 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lidoderm®
Commercially available Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain
Drug: Lidoderm®
Patients participated in a 6-week treatment period. Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain. Patients were stratified into the following groups at enrollment: acute (<6 weeks) LBP, subacute (6 weeks to <3 months) LBP, short-term chronic (3 months to 12 months, inclusive) LBP, and long-term chronic (>12 months LBP)
Other Name: Lidocaine patch 5%

  Eligibility

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

Inclusion Criteria:

  • Non-radicular LBP pain for

    ≤12 months (non-radicular defined as LBP that does not radiate below the mid-buttock and with no sensory symptoms in the leg)

  • Had LBP as the primary source of pain. Patients may have had mild to moderate spinal stenosis and no radicular symptoms
  • Had an average daily pain intensity score of >4 on a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as the patients have ever imagined (Question 5 of BPI) within 24 hours prior to the screening visit.
  • Had a normal neurological examination, including:

    • Motor strength
    • Sensory testing (light touch, pinprick, and vibration)
    • Deep tendon reflexes

Patients were eligible for participation in the long-term chronic (>12 months) group of the study if they also:

  • Had LBP for greater than one year. Patients may have had any of the following: lumbar degenerative disc disease, internal disc disruption, mild-to-severe spinal stenosis, degenerative scoliosis and spondylolisthesis, facet arthropathy

Exclusion Criteria:

  • Had a history of greater than one back surgery or one back surgery within 3 months of study entry
  • Had severe spinal stenosis and radicular symptoms
  • Had any other chronic pain condition that, in the opinion of the investigator, would have interfered with patient assessment of LBP relief
  • Had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry
  • Had received trigger point injections within 2 weeks prior to study entry
  • Had received Botox Injections within 3 months prior to study entry
  • Were taking a lidocaine-containing product that could not be discontinued while receiving Lidoderm
  • Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)

Patients were excluded from participation in the long-term chronic (>12 months) group if they also:

  • Had an undefined spinal diagnosis
  • Had a history of lumbar spine surgery within 6 months prior to study entry
  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: NCT00904540

Locations
United States, Arizona
Phoenix, Arizona, United States
United States, California
Mill Valley, California, United States
United States, Florida
Weston, Florida, United States
United States, New York
Bethpage, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, Pennsylvania
Allentown, Pennsylvania, United States
United States, Wisconsin
Madison, Wisconsin, 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: NCT00904540     History of Changes
Other Study ID Numbers: EN3220-006
Study First Received: May 15, 2009
Last Updated: February 8, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Low Back Pain
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 22, 2014