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

NCT00476151 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2011-05-17

Study results available
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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.

Conditions

  • Diabetic Peripheral Neuropathy
  • Neuralgia

Interventions

DRUG

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

topical cream applied daily for 4 weeks

DRUG

placebo cream

inactive placebo cream applied two times daily

Sponsors & Collaborators

  • EpiCept Corporation

    lead INDUSTRY

Principal Investigators

  • Robert H Dworkin, Ph.D. · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00476151 on ClinicalTrials.gov