Conditions: Post Herpetic Neuralgia PHN Neuropathy Nerve Pain
Keywords: Post Herpetic Neuralgia PHN Neuropathy Nerve Pain Topical
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 360
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare EpiCept™ NP-1 Topical Cream (2% ketamine / 4% amitriptyline) vs. Oral Gabapentin in the treatment of Postherpetic Neuralgia (PHN)

Detailed description:
This is a phase II, multicenter, double-blind, randomized, placebo-controlled, parallel group study of NP-1 and oral gabapentin in approximately 500 patients with PHN. Adult patients with pain resulting from PHN and meeting all other eligibility requirements will be screened for 7 days to determine their average daily pain intensity. Qualifying patients will be randomized on a 2:2:1 basis to NP-1, oral gabapentin, or placebo. The treatment period will be 4-Weeks.

Arms:
arm 1: Np-1 cream and placebo gabapentin arm 2: gabapentin caps and placebo cream arm 3: placebo cream and capsules

Interventions: intervention 1: EpiCept-NP-1 Cream intervention 2: Gabapentin Capsules intervention 3: placebo
Intervention descriptions: intervention 1: ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks intervention 2: 1800mg/day capsules for 4 weeks intervention 3: placebo cream and caps

Protocol document: