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: Amitriptyline/Ketamine Topical Cream	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

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:

The objective of this study is to evaluate the efficacy and safety of EpiCept™ NP-1 Topical Cream compared with placebo in patients with pain due to DPN by examining daily pain intensity scores. [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of responders [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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 cream: Placebo Comparator vehicle cream	Drug: Amitriptyline/Ketamine Topical Cream topical cream applied daily for 4 weeks
amitriptyline 4% ketamine 2% cream: Active Comparator active topical cream	Drug: Amitriptyline/Ketamine Topical Cream topical cream applied daily for 4 weeks

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.

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 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:	EpiCept Corporation ( Stephane Allard, Chief Medical Officer )
Study ID Numbers:	EPC2006-01
Study First Received:	May 17, 2007
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00476151 History of Changes
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:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Excitatory Amino Acid Agents
Pain
Signs and Symptoms
Neuromuscular Diseases
Sensory System Agents
Therapeutic Uses
Ketamine

Analgesics
Diabetes Complications
Antidepressive Agents
Excitatory Amino Acid Antagonists
Anesthetics, Intravenous
Diabetic Neuropathies
Neuralgia
Nervous System Diseases
Diabetes Mellitus
Central Nervous System Depressants
Endocrine System Diseases
Anesthetics, Dissociative
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Anesthetics, General

ClinicalTrials.gov processed this record on February 08, 2010