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

• 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 ]

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.

• Experimental: 1- Lidoderm®
  Lidoderm (lidocaine patch 5%), up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain
  Intervention: Drug: Lidoderm®
• Placebo Comparator: 2-Placebo
  Matching placebo, up to three patches applied topically once daily (q24h) to the area of maximal peripheral pain
  Intervention: Drug: Lidoderm®

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