Back to resultsA Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy
Primary Purpose
Diabetic Peripheral Neuropathy, Neuralgia
Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream
placebo cream
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Peripheral Neuropathy focused on measuring DPN, Diabetic, Nerve Pain
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
Sites / Locations
- Multiple Centers
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo cream
amitriptyline 4% ketamine 2% cream
Arm Description
vehicle cream
active topical cream
Outcomes
Primary Outcome Measures
Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00476151
Brief Title
A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
EpiCept Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathy, Neuralgia
Keywords
DPN, Diabetic, Nerve Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
226 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo cream
Arm Type
Placebo Comparator
Arm Description
vehicle cream
Arm Title
amitriptyline 4% ketamine 2% cream
Arm Type
Active Comparator
Arm Description
active topical cream
Intervention Type
Drug
Intervention Name(s)
EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream
Other Intervention Name(s)
EpiCept NP-1
Intervention Description
topical cream applied daily for 4 weeks
Intervention Type
Drug
Intervention Name(s)
placebo cream
Intervention Description
inactive placebo cream applied two times daily
Primary Outcome Measure Information:
Title
Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.
Description
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.
Time Frame
baseline and 4 weeks treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert H Dworkin, Ph.D.
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Multiple Centers
City
New Delhi
Country
India
12. IPD Sharing Statement
Learn more about this trial
A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy
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