Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy

This study has been completed.
Information provided by:
EpiCept Corporation Identifier:
First received: May 17, 2007
Last updated: April 19, 2011
Last verified: April 2011
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.

Condition Intervention Phase
Diabetic Peripheral Neuropathy
Drug: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream
Drug: placebo cream
Phase 2

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
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)

Resource links provided by NLM:

Further study details as provided by EpiCept Corporation:

Primary 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 ] [ Designated as safety issue: No ]
    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.

Enrollment: 226
Study Start Date: July 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo cream
vehicle cream
Drug: placebo cream
inactive placebo cream applied two times daily
Active Comparator: amitriptyline 4% ketamine 2% cream
active topical cream
Drug: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream
topical cream applied daily for 4 weeks
Other Name: EpiCept NP-1

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).

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00476151

Multiple Centers
New Delhi, India
Sponsors and Collaborators
EpiCept Corporation
Principal Investigator: Robert H Dworkin, Ph.D. University of Rochester
  More Information

Responsible Party: Stephane Allard, Chief Medical Officer, EpiCept Corporation Identifier: NCT00476151     History of Changes
Other Study ID Numbers: EPC2006-01 
Study First Received: May 17, 2007
Results First Received: September 28, 2010
Last Updated: April 19, 2011
Health Authority: United States: Food and Drug Administration
India: Ministry of Health

Keywords provided by EpiCept Corporation:
Nerve Pain

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Amitriptyline, perphenazine drug combination
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs processed this record on October 21, 2016