A Comparison of EpiCept⢠NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)
Information source: EpiCept Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post Herpetic Neuralgia; PHN; Neuropathy; Nerve Pain
Intervention: EpiCept-NP-1 Cream (Drug); Gabapentin Capsules (Drug); placebo (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: EpiCept Corporation Official(s) and/or principal investigator(s):
Robert H Dworkin, Ph.D., Principal Investigator, Affiliation: University of Rochester
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)
Clinical Details
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)
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Improvement in pain intensity
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Multiple Centers, New Delhi 110016, India
Additional Information
Starting date: July 2007
Ending date: June 2008
Last updated: April 21, 2008
|
