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

Overview

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.

Full Title of Study: “A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of EpiCept™ NP-1 Topical Cream in Patients With Pain From Diabetic Peripheral Neuropathy (DPN)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2008

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).

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

Arms, Groups and Cohorts

  • Placebo Comparator: placebo cream
    • vehicle cream
  • Active Comparator: amitriptyline 4% ketamine 2% cream
    • active topical cream

Clinical Trial Outcome Measures

Primary Measures

  • Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.
    • Time Frame: 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.

Participating in This Clinical Trial

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

  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • EpiCept Corporation
  • Provider of Information About this Clinical Study
    • Stephane Allard, Chief Medical Officer, EpiCept Corporation
  • Overall Official(s)
    • Robert H Dworkin, Ph.D., Principal Investigator, University of Rochester

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