Phase 2
Completed N=360
A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)
Post Herpetic Neuralgia · PHN · neuropathy · Nerve Pain
Source: ClinicalTrials.gov NCT00475904 ↗
Enrolled (actual)
360
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcomePrimary: 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
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)
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 |
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. Informational only — not medical advice.