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CompletedNCT00476151Updated May 17, 2011Results posted

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

A Phase 2 interventional study of EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream and placebo cream in Diabetic Peripheral Neuropathy and Neuralgia, sponsored by EpiCept Corporation. Completed at 1 site in India. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-17.

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

Phase
Phase 2
Study type
Interventional
Enrollment
226
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with pain in the lower extremities due to diabetic nerve pain.

Read the detailed description

This is a phase II, multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with chronic pain in the lower extremities due to diabetic peripheral neuropathy (DPN).

02

Conditions studied

  • Diabetic Peripheral Neuropathy
  • Neuralgia

Keywords

  • DPN
  • Diabetic
  • Nerve Pain
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 226 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases 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 chronic pain due to diabetic peripheral neuropathy (DPN) of at least 6 months duration are eligible if they have an average daily pain score of > 4 during the baseline week.

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 in this study
05

Study design

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

Study arms

  • Placebo comparator
    placebo cream

    vehicle cream

    Drug: placebo cream

  • Active comparator
    amitriptyline 4% ketamine 2% cream

    active topical cream

    Drug: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream

Interventions

  • DrugEpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream

    topical cream applied daily for 4 weeks

    Also known as: EpiCept NP-1

  • Drugplacebo cream

    inactive placebo cream applied two times daily

06

What researchers measure

Primary outcomes

  1. Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.

    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.

    Time frame: baseline and 4 weeks treatment

07

Results

Posted May 17, 2011

Participant flow

Participant flow — Overall Study
MilestonePlacebo CreamAmitriptyline 4% Ketamine 2% Cream
Started112114
Completed109107
Not completed37
Withdrew: Adverse event02
Withdrew: Protocol violation13
Withdrew: Withdrawal by subject20
Withdrew: Physician decision02

Outcome measures

PrimaryPlacebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.

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.

Time frame:
baseline and 4 weeks treatment
Reported as:
Least squares mean · units on a scale
Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.
units on a scalePlacebo CreamAmitriptyline 4% Ketamine 2% Cream
Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.1.64 (1.21 to 2.06)2.12 (1.72 to 2.53)
Statistical analysis
  • Placebo Cream vs Amitriptyline 4% Ketamine 2% Cream · ANCOVA · p = 0.083

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo Cream—0/112 (0%)16/112 (14.3%)
Amitriptyline 4% Ketamine 2% Cream—0/114 (0%)17/114 (14.9%)
Most frequent other events
Showing 10 of 28
Most frequent other events
EventPlacebo CreamAmitriptyline 4% Ketamine 2% Cream
DysesthesiaNervous system disorders3/1128/114
Aspartate aminotransferase increasedInvestigations0/1124/114
Blood urea increasedInvestigations3/1121/114
Blood lactate dehydrogenase increasedInvestigations1/1123/114
EosiniphiliaBlood and lymphatic system disorders2/1120/114
PyuriaRenal and urinary disorders2/1120/114
PruritusSkin and subcutaneous tissue disorders2/1120/114
RashSkin and subcutaneous tissue disorders2/1120/114
FlushingVascular disorders2/1121/114
Alanine aminotransferase increasedInvestigations1/1122/114

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Placebo CreamAmitriptyline 4% Ketamine 2% CreamTotal
<=18 years000
Between 18 and 65 years8694180
>=65 years262046
Age Continuous
Age Continuous(years)Placebo CreamAmitriptyline 4% Ketamine 2% CreamTotal
Mean55.05 ± 11.04456.06 ± 9.35055.56 ± 10.214
Sex: Female, Male
Sex: Female, Male(Participants)Placebo CreamAmitriptyline 4% Ketamine 2% CreamTotal
Female5549104
Male5765122
Region of Enrollment
Region of Enrollment(participants)Placebo CreamAmitriptyline 4% Ketamine 2% CreamTotal
India112114226
08

Study locations

1 site
  • Multiple Centers
    New Delhi, India
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00476151
Lead sponsor
EpiCept Corporation
First posted
May 21, 2007
Start date
Jul 2007
Primary completion
Apr 2008
Completion
Apr 2008
Results posted
May 17, 2011
Last update
May 17, 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 ↗

Not currently enrolling

This study is completed, as verified in Apr 2011. You cannot join it, but the record below documents what was studied.

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