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.
A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)
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)
Intervention / Treatment
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EpiCept-NP-1 Cream (DRUG)ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks
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Gabapentin Capsules (DRUG)1800mg/day capsules for 4 weeks
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Placebo (DRUG)placebo cream and caps
Condition or Disease
- Post Herpetic Neuralgia
- PHN
- Neuropathy
- Nerve Pain
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 360 (ACTUAL) |
| Funded by: | Industry |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
Masking |
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Clinical Trial Dates
| Start date: | Jul 01, 2007 | |
|---|---|---|
| Primary Completion: | Jun 01, 2008 | ACTUAL |
| Completion Date: | Jun 01, 2008 | ACTUAL |
| Study First Posted: | May 21, 2007 | ESTIMATED |
| Results First Posted: | Jul 06, 2011 | ESTIMATED |
| Last Updated: | Jul 25, 2011 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Location
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 Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Healthy Volunteers: | Yes |
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.
* 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.
Primary Outcomes
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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.
More Details
| NCT Number: | NCT00475904 |
|---|---|
| Other IDs: | EPC2007-02 |
| Study URL: | https://clinicaltrials.gov/study/NCT00475904 |
Last updated: Sep 29, 2023