Official Title: “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)”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Amitriptyline/Ketamine Topical Cream

Primary Measures

• The objective of this study is to evaluate the efficacy and safety of EpiCept™ NP-1 Topical Cream compared with placebo in patients with pain due to DPN by examining daily pain intensity scores.
  • Time Frame: 4 Weeks
    

Inclusion Criteria:

• Adult patients with chronic pain due to 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: EpiCept Corporation

Overall Clinical Trial Officials and Contacts

Robert H Dworkin, Ph.D. Principal Investigator University of Rochester  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00476151

Study ID Number: EPC2006-01

ClinicalTrials.gov Identifier: NCT00476151

Health Authority: United States: Food and Drug Administration