A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN) - Full Text View

Sponsor:	EpiCept Corporation
Information provided by:	EpiCept Corporation
ClinicalTrials.gov Identifier:	NCT00475904

Purpose

The purpose of this study is to compare EpiCept™ NP-1 Topical Cream (2% ketamine / 4% amitriptyline) vs. Oral Gabapentin in the treatment of Postherpetic Neuralgia (PHN)

Condition	Intervention	Phase
Post Herpetic Neuralgia PHN Neuropathy Nerve Pain	Drug: EpiCept-NP-1 Cream Drug: Gabapentin Capsules Drug: placebo	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 Phase II, Double-Blind, Randomized, Placebo-Controlled Non-inferiority Trial of EpiCept™ NP-1 Topical Cream (2% Ketamine / 4% Amitriptyline) vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)

Resource links provided by NLM:

MedlinePlus related topics: Shingles

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

U.S. FDA Resources

Further study details as provided by EpiCept Corporation:

Primary Outcome Measures:

Change in Pain Scores Comparing NP-1 Cream vs. Placebo Cream for Treatment of the Pain of Post Herpetic Neuralgia(PHN)From Baseline to 28 Days. [ Time Frame: baseline and 28 days ] [ Designated as safety issue: No ]
Difference in pain scores between NP-1 cream vs. placebo cream for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.
Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin [ Time Frame: baseline to 28 Days ] [ Designated as safety issue: No ]
Change in pain intensity scores between NP-1 cream vs. oral gabapentin for the treatment of the pain of PHN. Baseline pain scores were compared to the pain scores after 28 days of treatment. Pain scores were rated on a 11 point numerical rating scale (0-10) where 0 was no pain and 10 was worst possible pain.

Enrollment:	360
Study Start Date:	July 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: amitriptyline 4% ketamine 2% cream, placebo capsules Np-1 cream and placebo gabapentin	Drug: EpiCept-NP-1 Cream ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks Other Name: EpiCept-NP-1 cream
Active Comparator: gabapentin capsules, placebo cream gabapentin caps and placebo cream	Drug: Gabapentin Capsules 1800mg/day capsules for 4 weeks Other Name: gabapentin, neurontin
Placebo Comparator: placebo cream and capsules placebo cream and capsules	Drug: placebo placebo cream and caps Other Name: vehicle cream, placebo capsules

Detailed Description:

This is a phase II, multicenter, double-blind, randomized, placebo-controlled, parallel group study of NP-1 and oral gabapentin in approximately 500 patients with PHN. Adult patients with pain resulting from PHN and meeting all other eligibility requirements will be screened for 7 days to determine their average daily pain intensity. Qualifying patients will be randomized on a 2:2:1 basis to NP-1, oral gabapentin, or placebo. The treatment period will be 4-Weeks.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients with pain for ≥ 3 months following onset of a herpes zoster rash

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475904

Locations

India
Multiple Centers
New Delhi, India, 110016

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:	NCT00475904 History of Changes
Other Study ID Numbers:	EPC2007-02
Study First Received:	May 17, 2007
Results First Received:	April 20, 2011
Last Updated:	July 25, 2011
Health Authority:	United States: Food and Drug Administration; India: Ministry of Health

Keywords provided by EpiCept Corporation:

Post Herpetic Neuralgia
PHN
Neuropathy
Nerve Pain
Topical

Additional relevant MeSH terms:

Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Amitriptyline
Ketamine
Gabapentin
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
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Antipsychotic Agents
Tranquilizing Agents

ClinicalTrials.gov processed this record on February 09, 2012