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

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: NCT00475904
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : July 6, 2011
Last Update Posted : July 27, 2011
Sponsor:
Information provided by:
EpiCept Corporation

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Post Herpetic Neuralgia PHN Neuropathy Nerve Pain Drug: EpiCept-NP-1 Cream Drug: Gabapentin Capsules Drug: placebo Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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)
Study Start Date : July 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00475904


Locations
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India
Multiple Centers
New Delhi, India, 110016
Sponsors and Collaborators
EpiCept Corporation
Investigators
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Principal Investigator: Robert H Dworkin, Ph.D. University of Rochester
More Information
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Responsible Party: Stephane Allard, Chief Medical Officer, EpiCept Corporation
ClinicalTrials.gov Identifier: NCT00475904    
Other Study ID Numbers: EPC2007-02
First Posted: May 21, 2007    Key Record Dates
Results First Posted: July 6, 2011
Last Update Posted: July 27, 2011
Last Verified: July 2011
Keywords provided by EpiCept Corporation:
Post Herpetic Neuralgia
PHN
Neuropathy
Nerve Pain
Topical
Additional relevant MeSH terms:
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Neuralgia
Neuralgia, Postherpetic
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anticonvulsants
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents