Patients with a diagnosis of postherpetic neuralgia (PHN), diabetic neuropathy (DN), or low back pain (LBP) who were currently receiving an analgesic regimen that contained gabapentin participated in a Phase IV clinical trial to assess the effectiveness of Lidoderm® administered once daily (q24h) after 14 day in the treatment of PHN, DN, or LBP in patients who had a partial response to a regimen containing gabapentin.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
107
Patients participated in a 2-week treatment period. Commercially available Lidoderm (lidocaine patch 5%) was provided to patients with up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain.
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Plantation, Florida, United States
Unnamed facility
Marietta, Georgia, United States
Unnamed facility
Burr Ridge, Illinois, United States
Unnamed facility
Overland Park, Kansas, United States
Unnamed facility
Hackensack, New Jersey, United States
Unnamed facility
Altoona, Pennsylvania, United States
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Cudahy, Wisconsin, United States
Unnamed facility
Greenfield, Wisconsin, United States
...and 1 more locations
Average daily pain intensity (Brief Pain Inventory [BPI] Questions 3, 4, 5, and 6)
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Pain quality using the Neuropathic Pain Scale (NPS)
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Investigator and Patient Global Impression of Change
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Extent of numbness at the site of pain using the Numbness Questionnaire
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Patient Global Assessment of Pain Relief
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
Safety assessments included Adverse Events (AE), discontinuation due to AEs, physical and neurological examination results, vital signs, clinical laboratory data, sensory testing, numbness testing, and dermal assessments
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
QoL: Pain interference (BPI Question 9)
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
QoL: Patient Global Assessment of Patch Satisfaction
Time frame: Visits - V2 (Day 0), V3 (Day 7), V4/EOS (Day 14)
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