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Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00904475
Recruitment Status : Completed
First Posted : May 19, 2009
Last Update Posted : February 15, 2010
Sponsor:
Information provided by:
Endo Pharmaceuticals

Study Description
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Brief Summary:
Patients with moderate to severe chronic Low Back Pain (LBP) despite current analgesic treatment participated in a Phase IV clinical trial to evaluate the analgesic efficacy of the lidocaine patch 5% compared to placebo in treating moderate to severe chronic LBP.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Drug: Lidoderm® Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Prospective, Double-blind, Randomized, Placebo-Controlled, Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain
Study Start Date : April 2003
Actual Primary Completion Date : April 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1- Lidoderm®
Lidoderm (lidocaine patch 5%), up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain
 Drug: Lidoderm®
Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h.
Other Name: Lidocaine patch 5%
Placebo Comparator: 2-Placebo
Matching placebo, up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain
 Drug: Lidoderm®
Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or matching placebo patch. During the 6-week treatment period, patients used up to three patches daily applied q24h.
Other Name: Lidocaine patch 5%


Outcome Measures
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Primary Outcome Measures :
  1. Mean change in average daily pain intensity (BPI Question 5) from baseline week to the final week of treatment (primary endpoint) [ Time Frame: Visit - V2 (Day 0), V3 (Day 7), V4 (Day 14), V5 (Day 28), V6/EOS (Day 42) ]

Secondary Outcome Measures :
  1. Mean change from baseline to Week 2 and Week6/EOS in average daily pain intensity (BPI Question 5)
  2. Pain relief (BPI Question 8)
  3. Mean change from baseline to Week 2 and Week 6 in Pain Quality Assessment Scale (PQAS)
  4. Patient and Investigator Global Impression of Pain Relief at Week 6
  5. QoL: Change from baseline to Week 6 in pain interference with QoL (BPI Question 9) and Profile of Mood States (POMS)
  6. Safety assessments included AEs, discontinuations as a result of AEs, clinical laboratory tests, vital signs, physical examination, plasma lidocaine levels, dermal assessments and sking sensory testing

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Were currently experiencing moderate/severe pain despite current analgesic treatment
  2. Had daily moderate-to-severe LBP for at least 3 months duration
  3. Had a mean daily pain intensity score of >6 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) during the baseline week; patients had to complete daily diary assessments at least 5 of 7 days during the baseline week

Exclusion Criteria:

  1. Had a history of greater than one back surgery, or one back surgery within 3 months of study entry
  2. Had severe spinal stenosis
  3. Had chronic back pain of >12 months duration with an undefined spinal diagnosis
  4. Had radicular symptoms with radiation into the thigh or below (i.e., knee, calf, foot, etc.)
  5. Had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry
  6. Had received trigger point injections within 2 weeks prior to study entry
  7. Had received Botulinum Toxin Injections for LBP within 3 months prior to study entry
  8. Were taking a lidocaine-containing product that could not be discontinued while receiving study medication
  9. Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
  10. Had received Lidoderm for LBP in the past
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00904475


Locations
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United States, Alabama
Birmingham, Alabama, United States
Hueytown, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
United States, California
Mill Valley, California, United States
United States, Pennsylvania
Allentown, Pennsylvania, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
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Study Director: Sr. Director Endo Pharmaceuticals
More Information
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Responsible Party: Sr. Director, Clinical R&D, Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00904475    
Other Study ID Numbers: EN3220-011
First Posted: May 19, 2009    Key Record Dates
Last Update Posted: February 15, 2010
Last Verified: February 2010
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action