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

Phase 2

Completed

• Conditions: Post Herpetic Neuralgia; PHN; Neuropathy; Nerve Pain
• Interventions: Drug: EpiCept-NP-1 Cream; Drug: Gabapentin Capsules; Drug: placebo

• Registration Number: NCT00475904
• Lead Sponsor: EpiCept Corporation

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.

Study Timeline

• Study First Submitted: 2007-05-17
• Study First Submitted QC: 2007-05-18
• Study First Posted: 2007-05-21
• Study Start: 2007-07
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2011-04-20
• Results First Submitted QC: 2011-06-09
• Status Verified: 2011-07
• Results First Posted: 2011-07-06
• Last Update Submitted: 2011-07-25
• Last Update Posted: 2011-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Adult patients with pain for ≥ 3 months following onset of a herpes zoster rash

Exclusion Criteria

• Clinically significant intercurrent illness (e.g., endocrine, cardiac, hepatic, renal, neurologic, hematologic, skeletal) that the investigator determines could interfere with the efficacy or safety assessments.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
amitriptyline 4% ketamine 2% cream, placebo capsules	EpiCept-NP-1 Cream	Np-1 cream and placebo gabapentin
gabapentin capsules, placebo cream	Gabapentin Capsules	gabapentin caps and placebo cream
placebo cream and capsules	placebo	placebo cream and capsules

Primary Outcome Measures

Name	Time	Method
Change in Pain Scores Comparing NP-1 Cream vs. Placebo Cream for Treatment of the Pain of Post Herpetic Neuralgia(PHN)From Baseline to 28 Days.	baseline and 28 days	Difference in pain scores between NP-1 cream vs. placebo cream for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.
Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin	baseline to 28 Days	Change in pain intensity scores between NP-1 cream vs. oral gabapentin for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.

Trial Locations

Locations (1)

Multiple Centers; 🇮🇳 New Delhi, India