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

Overview

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)

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2008

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Active Comparator: amitriptyline 4% ketamine 2% cream, placebo capsules
    • Np-1 cream and placebo gabapentin
  • Active Comparator: gabapentin capsules, placebo cream
    • gabapentin caps and placebo cream
  • Placebo Comparator: placebo cream and capsules
    • placebo cream and capsules

Clinical Trial Outcome Measures

Primary Measures

  • 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.
    • Time Frame: 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
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • EpiCept Corporation
  • Provider of Information About this Clinical Study
    • Stephane Allard, Chief Medical Officer, EpiCept Corporation
  • Overall Official(s)
    • Robert H Dworkin, Ph.D., Principal Investigator, University of Rochester

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