A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy
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)
1 other identifier
interventional
226
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2007
CompletedFirst Posted
Study publicly available on registry
May 21, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedResults Posted
Study results publicly available
May 17, 2011
CompletedMay 17, 2011
April 1, 2011
9 months
May 17, 2007
September 28, 2010
April 19, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
baseline and 4 weeks treatment
Study Arms (2)
placebo cream
PLACEBO COMPARATORvehicle cream
amitriptyline 4% ketamine 2% cream
ACTIVE COMPARATORactive topical cream
Interventions
topical cream applied daily for 4 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Multiple Centers
New Delhi, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- EpiCept Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
Robert H Dworkin, Ph.D.
University of Rochester
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 17, 2007
First Posted
May 21, 2007
Study Start
July 1, 2007
Primary Completion
April 1, 2008
Study Completion
April 1, 2008
Last Updated
May 17, 2011
Results First Posted
May 17, 2011
Record last verified: 2011-04