Trial · NCT00475904
A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)
NCT00475904, Phase 2, Completed, EpiCept Corporation; results first posted 2011-07-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN). Trials, record NCT00475904. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00475904
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)
- NCT number
- NCT00475904
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 360 participants, actual
- Lead sponsor
- EpiCept Corporation
- Conditions
- Post Herpetic Neuralgia, PHN, Neuropathy, Nerve Pain
- Interventions
- EpiCept-NP-1 Cream, Gabapentin Capsules, placebo
- First posted
- 2007-05-21
- Last updated
- 2011-07-27
- Results first posted
- 2011-07-06
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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. | baseline and 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. |
| Primary | Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin | baseline to 28 Days | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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. | baseline and 28 days | This analysis was performed for the Intent To Treat (ITT) population using the ast Observation Carried Forward (LOCF) approach. | units on a scale | MEAN |
| PRIMARY | Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin | baseline to 28 Days | Intent To Treat (ITT) population using the Last Observation Carried Forward) LOCF imputation technique | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules | 2.424 | 95% Confidence Interval 2.07 to 2.78 | 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. | Gabapentin Capsules, Placebo Cream | 2.471 | 95% Confidence Interval 2.17 to 2.77 | 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. | Placebo Cream and Capsules | 1.877 | 95% Confidence Interval 1.43 to 2.32 | units on a scale | |
| Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin | Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules | 2.424 | 95% Confidence Interval 2.07 to 2.7 | units on a scale | |
| Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin | Gabapentin Capsules, Placebo Cream | 2.471 | 95% Confidence Interval 2.17 to 2.77 | units on a scale | |
| Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin | Placebo Cream and Capsules | 1.877 | 95% Confidence Interval 1.43 to 2.3 | units on a scale |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules | 140 | |
| Overall Study | STARTED | Gabapentin Capsules, Placebo Cream | 144 | |
| Overall Study | STARTED | Placebo Cream and Capsules | 76 | |
| Overall Study | COMPLETED | Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules | 125 | |
| Overall Study | COMPLETED | Gabapentin Capsules, Placebo Cream | 131 | |
| Overall Study | COMPLETED | Placebo Cream and Capsules | 72 | |
| Overall Study | NOT COMPLETED | Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules | 15 | |
| Overall Study | NOT COMPLETED | Gabapentin Capsules, Placebo Cream | 13 | |
| Overall Study | NOT COMPLETED | Placebo Cream and Capsules | 4 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vertigo | Ear and labyrinth disorders | Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules | 7 | 140 | 7 |
| other | Vertigo | Ear and labyrinth disorders | Gabapentin Capsules, Placebo Cream | 2 | 144 | 2 |
| other | Vertigo | Ear and labyrinth disorders | Placebo Cream and Capsules | 1 | 76 | 1 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules | ||
| Total, all-cause mortality | Gabapentin Capsules, Placebo Cream | ||
| Total, all-cause mortality | Placebo Cream and Capsules | ||
| Total, other adverse events | Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules | 7 | 140 |
| Total, other adverse events | Gabapentin Capsules, Placebo Cream | 2 | 144 |
| Total, other adverse events | Placebo Cream and Capsules | 1 | 76 |
| Total, serious adverse events | Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules | 0 | 140 |
| Total, serious adverse events | Gabapentin Capsules, Placebo Cream | 0 | 144 |
| Total, serious adverse events | Placebo Cream and Capsules | 0 | 76 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00475904
GET https://conductscience.org/api/trials/v1/NCT00475904/registered