Patients who had axial lower back pain (LBP) with or without radiation present for at least 3 months and had daily moderate to severe LBP as the primary source of pain participated in a Phase IV clinical trial to assess the efficacy of lidocaine patch 5% compared to celecoxib 200 mg in treating chronic axial LBP with and without radiation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
98
Patients participated in a 14-day washout period followed by a 12-week active treatment period. Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or celecoxib 200 mg.
Patients participated in a 14-day washout period followed by a 12-week active treatment period. Eligible patients were randomized equally to one of two groups: lidocaine patch 5% or celecoxib 200 mg.
Unnamed facility
Northport, Alabama, United States
Unnamed facility
Phoenix, Arizona, United States
Mean change from baseline to Week 12 in BPI average pain intensity score (Question 5).
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in daily pain intensity score as measured by Questions 3, 4, 5, and 6 of the BPI
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in BPI pain relief score (Question 8).
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in PQAS composite scores
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Mean change from baseline to Weeks 2, 4, 6, 8, and 12 in Oswestry Disability Index composite scores
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Investigator's Global Impression of Change in LBP at Week 12 (or premature discontinuation)
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Patient's Global Impression of Change in LBP at Week 12 (or premature discontinuation)
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Investigator's Global Assessment of Treatment Satisfaction at Week 12 (or premature discontinuation)
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
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Unnamed facility
Beverly Hills, California, United States
Unnamed facility
Encinitas, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
Spring Valley, California, United States
Unnamed facility
Longwood, Florida, United States
Unnamed facility
North Miami Beach, Florida, United States
Unnamed facility
Plantation, Florida, United States
Unnamed facility
Chicago, Illinois, United States
...and 11 more locations
Patient's Global Assessment of Treatment Satisfaction at Week 12 (or premature discontinuation)
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Safety assessments included AEs (including discontinuation due to AEs).
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Safety assessments included dermal assessment (lidocaine group only), skin sensory testing (lidocaine group only), clinical laboratory test results (including urinalysis, vital signs measurements, physical and neurological examinations, and body weight.
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)
Safety assessments included plasma lidocaine concentrations (lidocaine group only).
Time frame: Visit - V2 (Day 0), V3 (Day 14), V4 (Day 28), V5 (Day 42), V6 (Day 56), V7 (Day 84)