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

EpiCept Corporation226 enrolled

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

226

Conditions

Diabetic Peripheral Neuropathy Neuralgia

Interventions

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

topical cream applied daily for 4 weeks

placebo creamDRUG

inactive placebo cream applied two times daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Multiple Centers

New Delhi, India

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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