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.
Full Title of Study: “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)”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- 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 (DPN).
- 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
Arms, Groups and Cohorts
- Placebo Comparator: placebo cream
- vehicle cream
- Active Comparator: amitriptyline 4% ketamine 2% cream
- active topical cream
Clinical Trial Outcome Measures
- Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.
- Time Frame: 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.
Participating in This Clinical Trial
- 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.
- 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: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- EpiCept Corporation
- Provider of Information About this Clinical Study
- Stephane Allard, Chief Medical Officer, EpiCept Corporation
- Overall Official(s)
- Robert H Dworkin, Ph.D., Principal Investigator, University of Rochester
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