NCT00476151

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: EpiCept Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Diabetic Peripheral Neuropathy
• Neuralgia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2007-05-21
• Last updated: 2011-05-17
• Results posted: 2011-05-17

Locations

1 site across 1 country: India