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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00476151
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : May 17, 2011
Last Update Posted : May 17, 2011
Sponsor:
Information provided by:
EpiCept Corporation

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.

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

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : July 2007
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00476151


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

Responsible Party: Stephane Allard, Chief Medical Officer, EpiCept Corporation
ClinicalTrials.gov Identifier: NCT00476151     History of Changes
Other Study ID Numbers: EPC2006-01
First Posted: May 21, 2007    Key Record Dates
Results First Posted: May 17, 2011
Last Update Posted: May 17, 2011
Last Verified: April 2011

Keywords provided by EpiCept Corporation:
DPN
Diabetic
Nerve Pain

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuralgia
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Ketamine
Amitriptyline
Amitriptyline, perphenazine drug combination
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
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