Phase 2
N=360
A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)
Post Herpetic Neuralgia · PHN · Neuropathy · Nerve Pain
Bottom Line
View on ClinicalTrials.gov: NCT00475904 ↗Enrolled (actual)
360
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: 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. — 2.424; 2.471; 1.877 units on a scale — p=0.0441
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- EpiCept-NP-1 Cream (Drug); Gabapentin Capsules (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- EpiCept Corporation
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
2.424; 2.471; 1.877 | 0.0441 sig |
| PRIMARY Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin |
2.424; 2.471; 1.877 | 0.8409 |
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)
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.
Data sourced from ClinicalTrials.gov (NCT00475904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.