Patients with Chronic Axial Low Back Pain participated in a Phase II clinical trial to assess the efficacy of lidocaine 5% patch compared with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
215
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
Eligible patients were randomly allocated to receive one of two treatments for 12 weeks: lidocaine 5% patch or matching placebo patch.
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Birmingham, Alabama, United States
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Phoenix, Arizona, United States
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Carlsbad, California, United States
Pain intensity (Question 5 of the BPI)
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84)
Safety Assessments included AEs, dermal assessments, clinical laboratory results (including urinalysis), vital sign measurements, physical and neurological examinations, plasma lidocaine concentration
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day56), V7/EOS (Day 84)
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National City, California, United States
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Waterbury, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Port Orange, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Overland Park, Kansas, United States
...and 8 more locations