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Trial record 56 of 135 for:    AMITRIPTYLINE

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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Post Herpetic Neuralgia
PHN
Neuropathy
Nerve Pain
Interventions Drug: EpiCept-NP-1 Cream
Drug: Gabapentin Capsules
Drug: placebo
Enrollment 360
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules Gabapentin Capsules, Placebo Cream Placebo Cream and Capsules
Hide Arm/Group Description amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
Period Title: Overall Study
Started 140 144 76
Completed 125 131 72
Not Completed 15 13 4
Arm/Group Title Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules Gabapentin Capsules, Placebo Cream Placebo Cream and Capsules Total
Hide Arm/Group Description amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily Total of all reporting groups
Overall Number of Baseline Participants 140 144 76 360
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 144 participants 76 participants 360 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
106
  75.7%
109
  75.7%
55
  72.4%
270
  75.0%
>=65 years
34
  24.3%
35
  24.3%
21
  27.6%
90
  25.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 140 participants 144 participants 76 participants 360 participants
51.3  (16.04) 53.2  (15.53) 53.2  (16.47) 52.5  (15.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 144 participants 76 participants 360 participants
Female
56
  40.0%
49
  34.0%
30
  39.5%
135
  37.5%
Male
84
  60.0%
95
  66.0%
46
  60.5%
225
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
India Number Analyzed 140 participants 144 participants 76 participants 360 participants
140 144 76 360
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame baseline and 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was performed for the Intent To Treat (ITT) population using the ast Observation Carried Forward (LOCF) approach.
Arm/Group Title Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules Gabapentin Capsules, Placebo Cream Placebo Cream and Capsules
Hide Arm/Group Description:
amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
Overall Number of Participants Analyzed 135 138 76
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.424
(2.07 to 2.78)
2.471
(2.17 to 2.77)
1.877
(1.43 to 2.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules, Placebo Cream and Capsules
Comments In the initial analysis, the efficacy of the test treatment NP-1 cream was compared with placebo using an analysis of variance (ANOVA). The analysis was conducted using the ITT population to compare the mean changes in pain scores from baseline to endpoint for the 2 treatments; the LOCF approach was employed for patients who did not complete the trial.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0441
Comments a priori threshold for statistical significance was p<0.05
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.547
Confidence Interval (2-Sided) 95%
0.01 to 1.08
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.2709
Estimation Comments [Not Specified]
2.Primary Outcome
Title Change in Pain Intensity From Baseline to 28 Days of Treatment, Comparison Between NP-1 Topical Cream and Oral Gabapentin
Hide Description 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.
Time Frame baseline to 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent To Treat (ITT) population using the Last Observation Carried Forward) LOCF imputation technique
Arm/Group Title Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules Gabapentin Capsules, Placebo Cream Placebo Cream and Capsules
Hide Arm/Group Description:
amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
Overall Number of Participants Analyzed 135 138 76
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.424
(2.07 to 2.7)
2.471
(2.17 to 2.77)
1.877
(1.43 to 2.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules, Gabapentin Capsules, Placebo Cream
Comments the primary hypothesis of this study was that NP-1 topical cream (amitriptyline 4%/ketamine 2%) administered twice daily in doses of 4 gm for 4 weeks is not inferior to the standard treatment (oral gabapentin 600 mg 3 times daily) for relieving the pain of adult patients with PHN.
Type of Statistical Test Non-Inferiority or Equivalence
Comments To conclude that the NP-1 was not inferior to gabapentin, the upper limit of the 2-sided 90% CI for the difference between treatments for the endpoint mean pain score was required to be below the non-inferiority margin of 0.70.
Statistical Test of Hypothesis P-Value 0.8409
Comments To conclude that the NP-1 was not inferior to gabapentin, the upper limit of the 2-sided 90% CI for the difference between treatments for the endpoint mean pain score was required to be below the non-inferiority margin of 0.70.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.046
Confidence Interval (2-Sided) 90%
-0.33 to 0.43
Parameter Dispersion
Type: Standard Error of the mean
Value: .2311
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules Gabapentin Capsules, Placebo Cream Placebo Cream and Capsules
Hide Arm/Group Description amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
All-Cause Mortality
Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules Gabapentin Capsules, Placebo Cream Placebo Cream and Capsules
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules Gabapentin Capsules, Placebo Cream Placebo Cream and Capsules
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/140 (0.00%)      0/144 (0.00%)      0/76 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules Gabapentin Capsules, Placebo Cream Placebo Cream and Capsules
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/140 (5.00%)      2/144 (1.39%)      1/76 (1.32%)    
Ear and labyrinth disorders       
Vertigo  7/140 (5.00%)  7 2/144 (1.39%)  2 1/76 (1.32%)  1
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: EpiCept Corporation
Phone: 914-606-3500
EMail: sallard@epicept.com
Layout table for additonal 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