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

Sponsor:	EpiCept Corporation
Information provided by:	EpiCept Corporation
ClinicalTrials.gov Identifier:	NCT00476151

Purpose

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 Neuralgia	Drug: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream Drug: placebo cream	Phase II

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus Charcot-Marie-Tooth disease hereditary neuropathy with liability to pressure palsies

MedlinePlus related topics: Peripheral Nerve Disorders

Drug Information available for: Amitriptyline Amitriptyline hydrochloride Ketamine hydrochloride Ketamine Triavil

U.S. FDA Resources

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476151

Locations

India
Multiple Centers
New Delhi, India

Sponsors and Collaborators

EpiCept Corporation

Investigators

Principal Investigator:

Robert H Dworkin, Ph.D.

University of Rochester

More Information

No publications provided

Responsible Party:	Stephane Allard, Chief Medical Officer, EpiCept Corporation
ClinicalTrials.gov 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:

DPN
Diabetic
Nerve Pain

Additional relevant MeSH terms:

Neuralgia
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Diabetic Neuropathies
Pain
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders
Diabetes Complications

Diabetes Mellitus
Endocrine System Diseases
Amitriptyline
Ketamine
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012