NCT00475904

A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)

A Phase II, Double-Blind, Randomized, Placebo-Controlled Non-inferiority Trial of EpiCept™ NP-1 Topical Cream (2% Ketamine / 4% Amitriptyline) vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: EpiCept Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Herpetic Neuralgia
• PHN
• Neuropathy
• Nerve Pain

Interventions

Type	Name	Description
DRUG	EpiCept-NP-1 Cream	ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks
DRUG	Gabapentin Capsules	1800mg/day capsules for 4 weeks
DRUG	placebo	placebo cream and caps

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-05-21
• Last updated: 2011-07-27
• Results posted: 2011-07-06

Locations

1 site across 1 country: India