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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00475904
First Posted: May 21, 2007
Last Update Posted: July 27, 2011
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.
Information provided by:
EpiCept Corporation
  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 2

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


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 ]
    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 ]
    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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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

Responsible Party: Stephane Allard, Chief Medical Officer, EpiCept Corporation
ClinicalTrials.gov Identifier: NCT00475904     History of Changes
Other Study ID Numbers: EPC2007-02
First Submitted: May 17, 2007
First Posted: May 21, 2007
Results First Submitted: April 20, 2011
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:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Ketamine
Gabapentin
Amitriptyline
Amitriptyline, perphenazine drug combination
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers