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

NCT00475904 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2011-07-27

Study results available
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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)

Conditions

  • Post Herpetic Neuralgia
  • PHN
  • Neuropathy
  • Nerve Pain

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

Sponsors & Collaborators

  • EpiCept Corporation

    lead INDUSTRY

Principal Investigators

  • Robert H Dworkin, Ph.D. · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • India

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00475904 on ClinicalTrials.gov