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)

NCT00476151 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	EpiCept Corporation
Phase	Phase 2
Status	COMPLETED
Enrolment	226
Start date	2007-07
Completion	2008-04

Conditions

• Diabetic Peripheral Neuropathy
• Neuralgia

Interventions

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

Primary outcomes

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

Countries

India