Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE May 17, 2007
First Posted Date  ICMJE May 21, 2007
Results First Submitted Date  ICMJE April 20, 2011
Results First Posted Date  ICMJE July 6, 2011
Last Update Posted Date July 27, 2011
Study Start Date  ICMJE July 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 18, 2007)
Improvement in pain intensity [ Time Frame: 28 Days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison of EpiCept™ NP-1 Topical Cream vs. Oral Gabapentin in Postherpetic Neuralgia (PHN)
Official Title  ICMJE 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)
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)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Post Herpetic Neuralgia
  • PHN
  • Neuropathy
  • Nerve Pain
Intervention  ICMJE
  • Drug: EpiCept-NP-1 Cream
    ketamine 4% amitriptyline 2% cream, twice daily for 4 weeks
  • Drug: Gabapentin Capsules
    1800mg/day capsules for 4 weeks
    Other Name: gabapentin, neurontin
  • Drug: placebo
    placebo cream and caps
    Other Name: vehicle cream, placebo capsules
Study Arms  ICMJE
  • Active Comparator: amitriptyline 4% ketamine 2% cream, placebo capsules
    Np-1 cream and placebo gabapentin
    Intervention: Drug: EpiCept-NP-1 Cream
  • Active Comparator: gabapentin capsules, placebo cream
    gabapentin caps and placebo cream
    Intervention: Drug: Gabapentin Capsules
  • Placebo Comparator: placebo cream and capsules
    placebo cream and capsules
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2009)
360
Original Estimated Enrollment  ICMJE
 (submitted: May 18, 2007)
500
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00475904
Other Study ID Numbers  ICMJE EPC2007-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephane Allard, Chief Medical Officer, EpiCept Corporation
Study Sponsor  ICMJE EpiCept Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Robert H Dworkin, Ph.D. University of Rochester
PRS Account EpiCept Corporation
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP