Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 47 of 135 for:    AMITRIPTYLINE

A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy

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: NCT00476151
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : May 17, 2011
Last Update Posted : May 17, 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 Diabetic Peripheral Neuropathy
Neuralgia
Interventions Drug: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream
Drug: placebo cream
Enrollment 226
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Cream Amitriptyline 4% Ketamine 2% Cream
Hide Arm/Group Description vehicle cream applied twice daily for 4 weeks active topical cream applied twice daily for 4 weeks
Period Title: Overall Study
Started 112 114
Completed 109 107
Not Completed 3 7
Reason Not Completed
Adverse Event             0             2
Protocol Violation             1             3
Withdrawal by Subject             2             0
Physician Decision             0             2
Arm/Group Title Placebo Cream Amitriptyline 4% Ketamine 2% Cream Total
Hide Arm/Group Description vehicle cream applied twice daily for 4 weeks active topical cream applied twice daily for 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 112 114 226
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 114 participants 226 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
86
  76.8%
94
  82.5%
180
  79.6%
>=65 years
26
  23.2%
20
  17.5%
46
  20.4%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 112 participants 114 participants 226 participants
55.05  (11.044) 56.06  (9.350) 55.56  (10.214)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 114 participants 226 participants
Female
55
  49.1%
49
  43.0%
104
  46.0%
Male
57
  50.9%
65
  57.0%
122
  54.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
India Number Analyzed 112 participants 114 participants 226 participants
112 114 226
1.Primary Outcome
Title Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.
Hide Description diabetic peripheral neuropathy (DPN) pain is recorded on a numerical rating scale of 0 (no pain) to 10 (worst possible pain) at baseline and the endpoint of 4 weeks.
Time Frame baseline and 4 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT (Intention To Treat) completer population, LOCF (Last Observation Carried Forward) imputation
Arm/Group Title Placebo Cream Amitriptyline 4% Ketamine 2% Cream
Hide Arm/Group Description:
vehicle cream applied twice daily for 4 weeks
active topical cream applied twice daily for 4 weeks
Overall Number of Participants Analyzed 108 106
Least Squares Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.64
(1.21 to 2.06)
2.12
(1.72 to 2.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo Cream, Amitriptyline 4% Ketamine 2% Cream
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.083
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Cream Amitriptyline 4% Ketamine 2% Cream
Hide Arm/Group Description vehicle cream applied twice daily for 4 weeks active topical cream applied twice daily for 4 weeks
All-Cause Mortality
Placebo Cream Amitriptyline 4% Ketamine 2% Cream
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Cream Amitriptyline 4% Ketamine 2% Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/112 (0.00%)      0/114 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Cream Amitriptyline 4% Ketamine 2% Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/112 (14.29%)      17/114 (14.91%)    
Blood and lymphatic system disorders     
Eosiniphilia  1  2/112 (1.79%)  2 0/114 (0.00%)  0
Anemia  1  1/112 (0.89%)  1 0/114 (0.00%)  0
Eye disorders     
Conjunctivitis  1  1/112 (0.89%)  1 0/114 (0.00%)  0
General disorders     
Pain  1  1/112 (0.89%)  1 1/114 (0.88%)  1
Pyrexia  1  1/112 (0.89%)  1 1/114 (0.88%)  1
Edema  1  1/112 (0.89%)  1 0/114 (0.00%)  0
Infections and infestations     
Rhinitis  1  0/112 (0.00%)  0 1/114 (0.88%)  1
Upper Respiratory Infection  1  0/112 (0.00%)  0 1/114 (0.88%)  1
Investigations     
Aspartate aminotransferase increased  1  0/112 (0.00%)  0 4/114 (3.51%)  4
Blood lactate dehydrogenase increased  1  1/112 (0.89%)  1 3/114 (2.63%)  3
Blood urea increased  1  3/112 (2.68%)  3 1/114 (0.88%)  1
Alanine aminotransferase increased  1  1/112 (0.89%)  1 2/114 (1.75%)  2
Body temperature fluctuation  1  1/112 (0.89%)  1 0/114 (0.00%)  0
Electrocardiogram QT prolonged  1  1/112 (0.89%)  1 0/114 (0.00%)  0
Urine analysis abnormal  1  1/112 (0.89%)  1 0/114 (0.00%)  0
Metabolism and nutrition disorders     
Hyperkalemia  1  1/112 (0.89%)  1 1/114 (0.88%)  1
Hypocalcemia  1  1/112 (0.89%)  1 0/114 (0.00%)  0
Hyponatremia  1  1/112 (0.89%)  1 0/114 (0.00%)  0
Nervous system disorders     
Headache  1  0/112 (0.00%)  0 1/114 (0.88%)  1
Paresthesia  1  0/112 (0.00%)  0 1/114 (0.88%)  1
Somnolence  1  0/112 (0.00%)  0 1/114 (0.88%)  1
Dysesthesia  1  3/112 (2.68%)  3 8/114 (7.02%)  8
Renal and urinary disorders     
Pyuria  1  2/112 (1.79%)  2 0/114 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus  1  2/112 (1.79%)  2 0/114 (0.00%)  0
Rash  1  2/112 (1.79%)  2 0/114 (0.00%)  0
Dry skin  1  0/112 (0.00%)  0 1/114 (0.88%)  1
Skin exfoliation  1  0/112 (0.00%)  0 1/114 (0.88%)  1
Vascular disorders     
Flushing  1  2/112 (1.79%)  2 1/114 (0.88%)  1
Indicates events were collected by systematic assessment
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: deverton@epicept.com
Layout table for additonal information
Responsible Party: Stephane Allard, Chief Medical Officer, EpiCept Corporation
ClinicalTrials.gov Identifier: NCT00476151     History of Changes
Other Study ID Numbers: EPC2006-01
First Submitted: May 17, 2007
First Posted: May 21, 2007
Results First Submitted: September 28, 2010
Results First Posted: May 17, 2011
Last Update Posted: May 17, 2011