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

EpiCept

Status and phase: Completed; Phase 2

Conditions: Neuralgia; Diabetic Peripheral Neuropathy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00476151

EPC2006-01

Details and patient eligibility

About

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 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).

Enrollment: 226 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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226 participants in 2 patient groups, including a placebo group

placebo cream

Placebo Comparator group

Description:

vehicle cream

Treatment:

Drug: placebo cream

amitriptyline 4% ketamine 2% cream

Active Comparator group

Description:

active topical cream

Treatment:

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