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CompletedNCT00475904Updated Jul 27, 2011Results posted

A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)

A Phase 2 interventional study of EpiCept-NP-1 Cream and Gabapentin Capsules in Post Herpetic Neuralgia, PHN and Neuropathy, sponsored by EpiCept Corporation. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-07-27.

Sponsored by EpiCept Corporation · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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)

Read the 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.

02

Conditions studied

  • Post Herpetic Neuralgia
  • PHN
  • Neuropathy
  • Nerve Pain

Keywords

  • Post Herpetic Neuralgia
  • PHN
  • Neuropathy
  • Nerve Pain
  • Topical
03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 360 is above the median of 52 across 973 interventional studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

EpiCept Corporation is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients with pain for ≥ 3 months following onset of a herpes zoster rash

Exclusion criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
360 participants (actual)

Study arms

  • Active comparator
    amitriptyline 4% ketamine 2% cream, placebo capsules

    Np-1 cream and placebo gabapentin

    Drug: EpiCept-NP-1 Cream

  • Active comparator
    gabapentin capsules, placebo cream

    gabapentin caps and placebo cream

    Drug: Gabapentin Capsules

  • Placebo comparator
    placebo cream and capsules

    placebo cream and capsules

    Drug: placebo

Interventions

  • DrugEpiCept-NP-1 Cream

    ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks

  • DrugGabapentin Capsules

    1800mg/day capsules for 4 weeks

    Also known as: gabapentin, neurontin

  • Drugplacebo

    placebo cream and caps

    Also known as: vehicle cream, placebo capsules

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline and 28 days

  2. 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.

    Time frame: baseline to 28 Days

07

Results

Posted Jul 6, 2011

Participant flow

Participant flow — Overall Study
MilestoneAmitriptyline 4% Ketamine 2% Cream, Placebo CapsulesGabapentin Capsules, Placebo CreamPlacebo Cream and Capsules
Started14014476
Completed12513172
Not completed15134

Outcome measures

PrimaryChange 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.

Time frame:
baseline and 28 days
Reported as:
Mean · units on a scale
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.
units on a scaleAmitriptyline 4% Ketamine 2% Cream, Placebo CapsulesGabapentin Capsules, Placebo CreamPlacebo Cream and Capsules
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 (2.07 to 2.78)2.471 (2.17 to 2.77)1.877 (1.43 to 2.32)
Statistical analysis
  • Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules vs Placebo Cream and Capsules · ANOVA · p = 0.0441 (a priori threshold for statistical significance was p\<0.05) · Mean difference (final values): 0.547 · 95% CI 0.01 to 1.08
PrimaryChange 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.

Time frame:
baseline to 28 Days
Reported as:
Least squares mean · units on a scale
Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin
units on a scaleAmitriptyline 4% Ketamine 2% Cream, Placebo CapsulesGabapentin Capsules, Placebo CreamPlacebo Cream and Capsules
Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin2.424 (2.07 to 2.7)2.471 (2.17 to 2.77)1.877 (1.43 to 2.3)
Statistical analysis
  • Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules vs Gabapentin Capsules, Placebo Cream · ANCOVA · p = 0.8409 (To conclude that the NP-1 was not inferior to gabapentin, the upper limit of the 2-sided 90% CI for the difference between treatments for the endpoint mean pain score was required to be below the non-inferiority margin of 0.70.) · Mean difference (final values): 0.046 · 90% CI -0.33 to 0.43

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules—0/140 (0%)7/140 (5%)
Gabapentin Capsules, Placebo Cream—0/144 (0%)2/144 (1.4%)
Placebo Cream and Capsules—0/76 (0%)1/76 (1.3%)
Most frequent other events
Most frequent other events
EventAmitriptyline 4% Ketamine 2% Cream, Placebo CapsulesGabapentin Capsules, Placebo CreamPlacebo Cream and Capsules
VertigoEar and labyrinth disorders7/1402/1441/76

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Amitriptyline 4% Ketamine 2% Cream, Placebo CapsulesGabapentin Capsules, Placebo CreamPlacebo Cream and CapsulesTotal
<=18 years0000
Between 18 and 65 years10610955270
>=65 years34352190
Age Continuous
Age Continuous(years)Amitriptyline 4% Ketamine 2% Cream, Placebo CapsulesGabapentin Capsules, Placebo CreamPlacebo Cream and CapsulesTotal
Mean51.3 ± 16.0453.2 ± 15.5353.2 ± 16.4752.5 ± 15.91
Sex: Female, Male
Sex: Female, Male(Participants)Amitriptyline 4% Ketamine 2% Cream, Placebo CapsulesGabapentin Capsules, Placebo CreamPlacebo Cream and CapsulesTotal
Female564930135
Male849546225
Region of Enrollment
Region of Enrollment(participants)Amitriptyline 4% Ketamine 2% Cream, Placebo CapsulesGabapentin Capsules, Placebo CreamPlacebo Cream and CapsulesTotal
India14014476360
08

Study locations

1 site
  • Multiple Centers
    New Delhi, 110016, India
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00475904
Lead sponsor
EpiCept Corporation
First posted
May 21, 2007
Start date
Jul 2007
Primary completion
Jun 2008
Completion
Jun 2008
Results posted
Jul 6, 2011
Last update
Jul 27, 2011

Study contacts

Robert H Dworkin, Ph.D.
principal investigator · University of Rochester

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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