Trial · NCT00476151

A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy

NCT00476151, Phase 2, Completed, EpiCept Corporation; results first posted 2011-05-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy. Trials, record NCT00476151. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00476151

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy
NCT number: NCT00476151
Status: Completed
Phases: Phase 2
Enrollment: 226 participants, actual
Lead sponsor: EpiCept Corporation
Conditions: Diabetic Peripheral Neuropathy, Neuralgia
Interventions: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream, placebo cream
First posted: 2007-05-21
Last updated: 2011-05-17
Results first posted: 2011-05-17

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.	baseline and 4 weeks treatment	diabetic peripheral neuropathy (DPN) pain is recorded on a numerical rating scale of 0 (no pain) to 10 (worst possible pain) at baseline and the endpoint of 4 weeks.

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.	baseline and 4 weeks treatment	ITT (Intention To Treat) completer population, LOCF (Last Observation Carried Forward) imputation	units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.	Placebo Cream		1.64	95% Confidence Interval 1.21 to 2.06	units on a scale
Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.	Amitriptyline 4% Ketamine 2% Cream		2.12	95% Confidence Interval 1.72 to 2.53	units on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo Cream	112
Overall Study	STARTED	Amitriptyline 4% Ketamine 2% Cream	114
Overall Study	COMPLETED	Placebo Cream	109
Overall Study	COMPLETED	Amitriptyline 4% Ketamine 2% Cream	107
Overall Study	NOT COMPLETED	Placebo Cream	3
Overall Study	NOT COMPLETED	Amitriptyline 4% Ketamine 2% Cream	7

Source ClinicalTrials.gov

Adverse events56

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	Eosiniphilia	Blood and lymphatic system disorders	Placebo Cream	2	112	2
other	Eosiniphilia	Blood and lymphatic system disorders	Amitriptyline 4% Ketamine 2% Cream	0	114	0
other	Anemia	Blood and lymphatic system disorders	Placebo Cream	1	112	1
other	Anemia	Blood and lymphatic system disorders	Amitriptyline 4% Ketamine 2% Cream	0	114	0
other	Conjunctivitis	Eye disorders	Placebo Cream	1	112	1
other	Conjunctivitis	Eye disorders	Amitriptyline 4% Ketamine 2% Cream	0	114	0
other	Pain	General disorders	Placebo Cream	1	112	1
other	Pain	General disorders	Amitriptyline 4% Ketamine 2% Cream	1	114	1
other	Pyrexia	General disorders	Placebo Cream	1	112	1
other	Pyrexia	General disorders	Amitriptyline 4% Ketamine 2% Cream	1	114	1

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo Cream
Total, all-cause mortality	Amitriptyline 4% Ketamine 2% Cream
Total, other adverse events	Placebo Cream	16	112
Total, other adverse events	Amitriptyline 4% Ketamine 2% Cream	17	114
Total, serious adverse events	Placebo Cream	0	112
Total, serious adverse events	Amitriptyline 4% Ketamine 2% Cream	0	114

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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Amitriptyline 4% Ketamine 2% Cream vs Placebo Cream: serious adverse events

Source Trial comparisons

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00476151

GET https://conductscience.org/api/trials/v1/NCT00476151/events?page=2

API reference For AI assistants