A Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions
A Study Of Lidocaine Patch 5% Alone, Gabapentin Alone, And Lidocaine Patch 5% And Gabapentin In Combination For The Relief Of Pain In Patients With Diverse Peripheral Neuropathic Pain Conditions
Patients with postherpetic neuralgia (PHN), diabetic neuropathy (DN), complex regional pain
 syndrome (CRPS), carpal tunnel syndrome, HIV neuropathy, idiopathic sensory neuropathy, or
 other peripheral neuropathy participated in a Phase IV clinical trial to assess the
 comparative efficacy and safety of Lidoderm monotherapy versus gabapentin monotherapy in
 treating a diverse group of peripheral neuropathic pain patients.
Inclusion Criteria:

 1. Had a diagnosis of PHN, DN, CRPS, carpal tunnel syndrome, HIV neuropathy, idiopathic
 sensory neuropathy, or other peripheral neuropathy (upon mutual agreement of the
 sponsor and investigator)

 2. Patients with PHN must have had pain >3 months after rash healing

 3. Patients with DN must have had Type I or II diabetes and painful distal symmetric
 sensorimotor polyneuropathy with or without dynamic allodynia of the lower extremities

 4. Patients with CRPS must have met current IASP (International Association for the Study
 of Pain) diagnostic criteria

 5. Patients with carpal tunnel syndrome must have had a diagnosis by combination clinical
 neurological examination (e.g., Phalen's and Tinel's signs), electrodiagnostic
 testing, and daily painful symptoms of at least 3 months' duration

 6. Patients with HIV neuropathy must have had HIV, subjective symptoms of painful
 peripheral neuropathy, and daily painful symptoms of at least 3 months' duration

 7. Patients with idiopathic sensory neuropathy must have had pain of at least 3 months'
 duration

 8. Reached an average daily pain rating during the baseline week of pain ratings greater
 than 4 on the 0-to-10 numerical pain rating scale (Question 5 of the BPI)

 9. Had never received an analgesic regimen that contained lidocaine or gabapentin

 Exclusion Criteria:

 1. Had a neurological condition other than that associated with their pain diagnosis
 which, in the opinion of the investigator, would interfere with their ability to
 participate in the study

 2. Were taking a lidocaine-containing product that could not be discontinued while
 receiving lidocaine

 3. Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)