Conditions: Diabetic Peripheral Neuropathy Neuralgia
Keywords: DPN Diabetic Nerve Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 226
Healthy volunteers: no

Brief 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).

Arms:
arm 1: vehicle cream arm 2: active topical cream

Interventions: intervention 1: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream intervention 2: placebo cream
Intervention descriptions: intervention 1: topical cream applied daily for 4 weeks intervention 2: inactive placebo cream applied two times daily

Protocol document: