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

Neuropathy Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475904
• Other study ID #: EPC2007-02
• Status: Completed
• Phase: Phase 2
• First received: May 17, 2007
• Last updated: July 25, 2011
• Start date: July 2007
• Est. completion date: June 2008

Study information

• Verified date: July 2011
• Source: EpiCept Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIndia: Ministry of Health
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nerve Pain
• Neuralgia
• Neuralgia, Postherpetic
• Neuropathy
• PHN
• Post Herpetic Neuralgia

Intervention

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

Locations

Country	Name	City	State
India	Multiple Centers	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
EpiCept Corporation

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	baseline and 28 days	No
Primary	Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin	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.	baseline to 28 Days	No