Back to resultsA Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)
Primary Purpose
Post Herpetic Neuralgia, PHN, Neuropathy
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
EpiCept-NP-1 Cream
Gabapentin Capsules
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post Herpetic Neuralgia focused on measuring Post Herpetic Neuralgia, PHN, Neuropathy, Nerve Pain, Topical
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.
Sites / Locations
- Multiple Centers
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
amitriptyline 4% ketamine 2% cream, placebo capsules
gabapentin capsules, placebo cream
placebo cream and capsules
Arm Description
Np-1 cream and placebo gabapentin
gabapentin caps and placebo cream
placebo cream and capsules
Outcomes
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.
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00475904
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
EpiCept Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Herpetic Neuralgia, PHN, Neuropathy, Nerve Pain
Keywords
Post Herpetic Neuralgia, PHN, Neuropathy, Nerve Pain, Topical
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
amitriptyline 4% ketamine 2% cream, placebo capsules
Arm Type
Active Comparator
Arm Description
Np-1 cream and placebo gabapentin
Arm Title
gabapentin capsules, placebo cream
Arm Type
Active Comparator
Arm Description
gabapentin caps and placebo cream
Arm Title
placebo cream and capsules
Arm Type
Placebo Comparator
Arm Description
placebo cream and capsules
Intervention Type
Drug
Intervention Name(s)
EpiCept-NP-1 Cream
Intervention Description
ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Gabapentin Capsules
Other Intervention Name(s)
gabapentin, neurontin
Intervention Description
1800mg/day capsules for 4 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
vehicle cream, placebo capsules
Intervention Description
placebo cream and caps
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
baseline and 28 days
Title
Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin
Description
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.
Time Frame
baseline to 28 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert H Dworkin, Ph.D.
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Multiple Centers
City
New Delhi
ZIP/Postal Code
110016
Country
India
12. IPD Sharing Statement
Learn more about this trial
A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)
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