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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
102
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.
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.
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Hueytown, Alabama, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Mill Valley, California, United States
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)
Mean change from baseline to Week 2 and Week6/EOS in average daily pain intensity (BPI Question 5)
Pain relief (BPI Question 8)
Mean change from baseline to Week 2 and Week 6 in Pain Quality Assessment Scale (PQAS)
Patient and Investigator Global Impression of Pain Relief at Week 6
QoL: Change from baseline to Week 6 in pain interference with QoL (BPI Question 9) and Profile of Mood States (POMS)
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
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Unnamed facility
Allentown, Pennsylvania, United States
Unnamed facility
Salt Lake City, Utah, United States