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
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
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 ]

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. ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Differences between the 60- and 30-minute Control groups prevented pooling according to prespecified criteria resulting in treatment comparisons between 60- and 30-minute NGX-4010 groups and their respective Control groups with relatively low power.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Trudy Vanhove, VP Clinical Development
Organization: NeurogesX
phone: 650-393-7444
e-mail: tvanhove@neurogesx.com


No publications provided by NeurogesX

Publications automatically indexed to this study:

Responsible Party: Trudy Vanhove, VP Clinical Development, NeurogesX
ClinicalTrials.gov Identifier: NCT00321672     History of Changes
Other Study ID Numbers: C119
Study First Received: May 2, 2006
Results First Received: June 16, 2010
Last Updated: May 13, 2011
Health Authority: United States: Food and Drug Administration