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

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

Overview[ - collapse ][ - ]

Purpose	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)
Condition	Post Herpetic Neuralgia PHN Neuropathy Nerve Pain
Intervention	Drug: EpiCept-NP-1 Cream Drug: Gabapentin Capsules Drug: placebo
Phase	Phase 2
Sponsor	EpiCept Corporation
Responsible Party	EpiCept Corporation
ClinicalTrials.gov Identifier	NCT00475904
First Received	May 17, 2007
Last Updated	July 25, 2011
Last verified	July 2011

Tracking Information[ + expand ][ + ]

First Received Date	May 17, 2007
Last Updated Date	July 25, 2011
Start Date	July 2007
Estimated Primary Completion Date	June 2008
Current Primary Outcome 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] [Designated as safety issue: No]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] [Designated as safety issue: No]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.
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)
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)
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 Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Post Herpetic Neuralgia PHN Neuropathy Nerve Pain
Intervention	Drug: EpiCept-NP-1 Cream ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks Other Names: EpiCept-NP-1 creamDrug: Gabapentin Capsules 1800mg/day capsules for 4 weeks Other Names: gabapentin, neurontinDrug: placebo placebo cream and caps Other Names: vehicle cream, placebo capsules
Study Arm (s)	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

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	360
Estimated Completion Date	June 2008
Estimated Primary Completion Date	June 2008
Eligibility Criteria	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	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	India

Administrative Information[ + expand ][ + ]

NCT Number	NCT00475904
Other Study ID Numbers	EPC2007-02
Has Data Monitoring Committee	No
Information Provided By	EpiCept Corporation
Study Sponsor	EpiCept Corporation
Collaborators	Not Provided
Investigators	Principal Investigator: Robert H Dworkin, Ph.D. University of Rochester
Verification Date	July 2011

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