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Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy

This study has been completed.
Sponsor:
Information provided by:
NeurogesX
ClinicalTrials.gov Identifier:
NCT00321672
First received: May 2, 2006
Last updated: May 13, 2011
Last verified: May 2011
History of Changes
Results First Received: June 16, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Pain
HIV Infections
Peripheral Nervous System Diseases
Interventions: Drug: NGX-4010, 8% capsaicin patch
Drug: 0.04% capsaicin patch

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
NGX-4010, 60 Minutes Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
Control Group, 60 Minutes Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
NGX-4010, 30 Minutes Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
Control Group , 30 Minutes Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.

Participant Flow:   Overall Study
    NGX-4010, 60 Minutes     Control Group, 60 Minutes     NGX-4010, 30 Minutes     Control Group , 30 Minutes  
STARTED     165     89 [1]   167     73 [1]
COMPLETED     153     81     156     71  
NOT COMPLETED     12     8     11     2  
Withdrawal by Subject                 5                 1                 2                 0  
Noncompliance                 1                 2                 1                 0  
Adverse Event                 1                 1                 0                 0  
Lack of Efficacy                 1                 1                 0                 0  
Lost to Follow-up                 2                 0                 4                 2  
Death                 1                 0                 0                 0  
Too far to travel for visits                 1                 0                 0                 0  
Incarcerated                 0                 0                 2                 0  
Moved out of state                 0                 1                 1                 0  
Protocol Violation                 0                 0                 1                 0  
Diagnosis of testicular cancer                 0                 1                 0                 0  
Extensive travel required for new job                 0                 1                 0                 0  
[1] One randomized to 30 minutes received 60 minutes. Under 30 for efficacy and under 60 for safety.



  Baseline Characteristics
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Reporting Groups
  Description
NGX-4010, 60 Minutes Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
Control Group, 60 Minutes Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
NGX-4010, 30 Minutes Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
Control Group , 30 Minutes Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
Total Total of all reporting groups

Baseline Measures
    NGX-4010, 60 Minutes     Control Group, 60 Minutes     NGX-4010, 30 Minutes     Control Group , 30 Minutes     Total  
Number of Participants  
[units: participants]
 		  165     90     167     72     494  
Age [1]
[units: years]
Mean ± Standard Deviation 		  49.0  ± 8.52     50.1  ± 9.33     50.5  ± 8.34     49.3  ± 7.78     49.7  ± 8.5  
Gender [1]
[units: participants]
 		         
Female     17     11     25     9     62  
Male     148     79     142     63     432  
[1]

60 minutes control group - one randomized 30 minutes received 60 minutes. Under 30 for efficacy and under 60

30 minutes control goup, one randomized to 30 minutes received 60 minutes. Under 30 for efficacy and under 60 for safety.



  Outcome Measures
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1.  Primary:   The Primary Measure of Efficacy Was the Percent Change in the “Average Pain for the Past 24 Hours” Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12.   [ Time Frame: Weeks 2-12 ]
  Show Outcome Measure 1

2.  Secondary:   Absolute Change in the Mean “Average Pain for the Past 24 Hours” Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12.   [ Time Frame: Weeks 2-12. ]
  Show Outcome Measure 2

3.  Secondary:   Proportion of Subjects Reaching 30% Decrease in Their Mean “Average Pain for the Past 24 Hours” Numeric Pain Rating Scale (NPRS) Score From Baseline During Weeks 2 to 12   [ Time Frame: Weeks 2-12 ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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