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

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)

Intervention / Treatment

  • EpiCept-NP-1 Cream (DRUG)
    ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks
  • Gabapentin Capsules (DRUG)
    1800mg/day capsules for 4 weeks
  • Placebo (DRUG)
    placebo cream and caps

Condition or Disease

  • Post Herpetic Neuralgia
  • PHN
  • Neuropathy
  • Nerve Pain

Phase

Study Design

Study type: INTERVENTIONAL
Status: Completed
Study results: No Results Available
Age: 18 Years and older   (Adult, Older Adult)
Enrollment: 360 (ACTUAL)
Funded by: Industry
Allocation: Randomized
Primary Purpose: Treatment

Masking

Clinical Trial Dates

Start date: Jul 01, 2007
Primary Completion: Jun 01, 2008 ACTUAL
Completion Date: Jun 01, 2008 ACTUAL
Study First Posted: May 21, 2007 ESTIMATED
Results First Posted: Jul 06, 2011 ESTIMATED
Last Updated: Jul 25, 2011

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

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.

Eligibility Criteria

Sex: All
Minimum Age: 18
Healthy Volunteers: Yes

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.

Primary Outcomes
  • 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 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.

More Details

NCT Number: NCT00475904
Other IDs: EPC2007-02
Study URL: https://clinicaltrials.gov/study/NCT00475904
Last updated: Sep 29, 2023