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

This study has been completed.
Sponsor:
Information provided by:
EpiCept Corporation
ClinicalTrials.gov Identifier:
NCT00476151
First received: May 17, 2007
Last updated: April 19, 2011
Last verified: April 2011
  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 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).

  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
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 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:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Nervous System Diseases
Neuromuscular Diseases
Amitriptyline
Amitriptyline, perphenazine drug combination
Ketamine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Analgesics, Non-Narcotic
Anesthetics
Anesthetics, Dissociative
Anesthetics, General
Anesthetics, Intravenous
Antidepressive Agents
Antidepressive Agents, Tricyclic
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 21, 2014