A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy
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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: April 2008
Detailed Clinical Trial 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).
Intervention(s) in this Clinical Trial
- 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 in this Clinical Trial
- Placebo Comparator: placebo cream
- vehicle cream
- Active Comparator: amitriptyline 4% ketamine 2% cream
- active topical cream
Outcome Measures for this Clinical Trial
Primary 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
Safety Issue?: No
- Time Frame: baseline and 4 weeks treatment
Criteria for Participation in this Clinical Trial
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
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
Clinical Trial Investigator Information
Lead Investigator: EpiCept Corporation Industry
Overall Clinical Trial Officials and Contacts
Robert H Dworkin, Ph.D. Principal Investigator University of Rochester
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00476151
