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
Postherpetic Neuralgia, Diabetic Neuropathy, Complex Regional Pain Syndrome
About this trial
This is an interventional treatment trial for Postherpetic Neuralgia
Eligibility Criteria
Inclusion Criteria:
- 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)
- Patients with PHN must have had pain >3 months after rash healing
- 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
- Patients with CRPS must have met current IASP (International Association for the Study of Pain) diagnostic criteria
- 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
- Patients with HIV neuropathy must have had HIV, subjective symptoms of painful peripheral neuropathy, and daily painful symptoms of at least 3 months' duration
- Patients with idiopathic sensory neuropathy must have had pain of at least 3 months' duration
- 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)
- Had never received an analgesic regimen that contained lidocaine or gabapentin
Exclusion Criteria:
- 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
- Were taking a lidocaine-containing product that could not be discontinued while receiving lidocaine
- Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Placebo Comparator
Experimental
Active Comparator
Other
placebo capsules + placebo patch
placebo capsules + Lidoderm patch (Lidocaine Group)
Gabapentin capsules 1800 mg/day + placebo patch
Gabapentin capsules 1800 mg/day + Lidoderm patch
Placebo to match lidocaine patch; up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain AND Placebo capsules to match gabapentin for oral dosing
Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain AND Placebo capsules to match gabapentin for oral dosing
Gabapentin 300 mg capsules for oral dosing at a dose of 1800 mg/day AND Placebo patch to match lidocaine patch; up to four patches applied topically daily (q24h) to the area of maximal peripheral pain
Gabapentin 1800 mg/day AND Lidoderm (lidocaine patch 5%), up to four patches applied topically once daily (q24h) to the area of maximal peripheral pain