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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Diabetic Peripheral Neuropathy Neuralgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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placebo cream

vehicle cream

Group Type PLACEBO_COMPARATOR

placebo cream

Intervention Type DRUG

inactive placebo cream applied two times daily

amitriptyline 4% ketamine 2% cream

active topical cream

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

topical cream applied daily for 4 weeks

Interventions

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

topical cream applied daily for 4 weeks

Intervention Type DRUG

placebo cream

inactive placebo cream applied two times daily

Intervention Type DRUG

Other Intervention Names

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EpiCept NP-1

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No