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| Sponsored by: |
EpiCept Corporation |
| Information provided by: | EpiCept Corporation |
| ClinicalTrials.gov Identifier: | NCT00475904 |
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 | Intervention | Phase |
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Post Herpetic Neuralgia PHN Neuropathy Nerve Pain |
Drug: EpiCept-NP-1 Cream Drug: Gabapentin Capsules Drug: placebo |
Phase II |
| MedlinePlus related topics: | Shingles |
| ChemIDplus related topics: | Amitriptyline Amitriptyline hydrochloride Gabapentin Ketamine Ketamine hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| 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) |
| Estimated Enrollment: | 500 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | June 2008 |
| Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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A, 1: Active Comparator
Np-1 cream and placebo gabapentin
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Drug: EpiCept-NP-1 Cream
ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks
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a,2: Active Comparator
gabapentin caps and placebo cream
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Drug: Gabapentin Capsules
1800mg/day capsules for 4 weeks
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p, 1: Placebo Comparator
placebo cream and capsules
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Drug: placebo
placebo cream and caps
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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
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | EPC2007-02 |
| First Received: | May 17, 2007 |
| Last Updated: | April 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00475904 |
| Health Authority: | United States: Food and Drug Administration; India: Ministry of Health |
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