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OpenTrials
Completed

NCT Number: NCT00904475

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

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.

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Were currently experiencing moderate/severe pain despite current analgesic treatment
  • Had daily moderate-to-severe LBP for at least 3 months duration
  • 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

  • Had a history of greater than one back surgery, or one back surgery within 3 months of study entry
  • Had severe spinal stenosis
  • Had chronic back pain of >12 months duration with an undefined spinal diagnosis
  • Had radicular symptoms with radiation into the thigh or below (i.e., knee, calf, foot, etc.)
  • 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 Botulinum Toxin Injections for LBP within 3 months prior to study entry
  • Were taking a lidocaine-containing product that could not be discontinued while receiving study medication
  • Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
  • Had received Lidoderm for LBP in the past

Treatment and study plan

Lidoderm®

Drug

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 names: Lidocaine patch 5%

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Endo USA Inc., a Keenova Therapeutics Company

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2003
First posted
May 19, 2009
Registry last updated
Feb 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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