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

This study has been completed.
Sponsor:
Information provided by:
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00904475
First received: May 15, 2009
Last updated: February 12, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Chronic Low Back Pain
Drug: Lidoderm®
Phase 4

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 Prospective, Prospective, Double-blind, Randomized, Placebo-Controlled, Pilot Study of the Efficacy and Safety of Lidoderm Patch in the 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 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline to Week 2 and Week6/EOS in average daily pain intensity (BPI Question 5) [ Designated as safety issue: No ]
  • Pain relief (BPI Question 8) [ Designated as safety issue: No ]
  • Mean change from baseline to Week 2 and Week 6 in Pain Quality Assessment Scale (PQAS) [ Designated as safety issue: No ]
  • Patient and Investigator Global Impression of Pain Relief at Week 6 [ Designated as safety issue: No ]
  • QoL: Change from baseline to Week 6 in pain interference with QoL (BPI Question 9) and Profile of Mood States (POMS) [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: Yes ]

Enrollment: 102
Study Start Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00904475

Locations
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
Study Director: Sr. Director Endo Pharmaceuticals
  More Information

No publications provided

Responsible Party: Sr. Director, Clinical R&D, Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00904475     History of Changes
Other Study ID Numbers: EN3220-011
Study First Received: May 15, 2009
Last Updated: February 12, 2010
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 July 31, 2014