CompletedPhase 2ketamine

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

NCT ID

NCT00476151

Target Enrollment

226 participants

Start Date

2007-07

Est. Completion

2008-04

About This Study

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.

Conditions Studied

Diabetic Peripheral NeuropathyNeuralgia

Interventions

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

Eligibility

Age:18 Years - N/A

Healthy Volunteers:No

View full eligibility criteria

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

Study Locations (1)

Multiple Centers