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Study of NGX-4010 for the Treatment of Painful HIV-Associated 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: NCT00321672
Recruitment Status : Completed
First Posted : May 4, 2006
Results First Posted : June 14, 2011
Last Update Posted : June 14, 2011
Sponsor:
Information provided by:
NeurogesX

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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
Enrollment 494
Recruitment Details  
Pre-assignment Details  
Arm/Group Title NGX-4010, 60 Minutes Control Group, 60 Minutes NGX-4010, 30 Minutes Control Group , 30 Minutes
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 165 89 [1] 167 73 [1]
Completed 153 81 156 71
Not Completed 12 8 11 2
Reason Not Completed
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.
Arm/Group Title NGX-4010, 60 Minutes Control Group, 60 Minutes NGX-4010, 30 Minutes Control Group , 30 Minutes Total
Hide Arm/Group Description 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 165 90 167 72 494
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 165 participants 90 participants 167 participants 72 participants 494 participants
49.0  (8.52) 50.1  (9.33) 50.5  (8.34) 49.3  (7.78) 49.7  (8.5)
[1]
Measure Description:

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.

Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 165 participants 90 participants 167 participants 72 participants 494 participants
Female
17
  10.3%
11
  12.2%
25
  15.0%
9
  12.5%
62
  12.6%
Male
148
  89.7%
79
  87.8%
142
  85.0%
63
  87.5%
432
  87.4%
[1]
Measure Description:

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.

1.Primary Outcome
Title 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.
Hide Description Efficacy was assessed by daily Numeric Pain Rating Scale (NPRS) capturing "average pain for the past 24 hours" for painful HIV-associated neuropathy area(s) at approximately 9 PM every evening throughout the 12-week study period. The NPRS is an 11-point scale (0 to 10) with 0 indicating no pain and 10 indicating the worst possible pain.
Time Frame Weeks 2-12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analyses were intention to treat (ITT). A modified last observation carried forward (LOCF) approach was used to impute missing data. Each NGX-4010 group was compared with its respective control group.
Arm/Group Title NGX-4010, 60 Minutes Control Group, 60 Minutes NGX-4010, 30 Minutes Control Group , 30 Minutes NGX-4010 Total Control, Total
Hide Arm/Group Description:
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.
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.
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.
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.
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 or 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 30 or 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.
Overall Number of Participants Analyzed 165 90 167 72 332 162
Least Squares Mean (Standard Error)
Unit of Measure: Percent Change from baseline
-32.8  (2.41) -30.0  (3.27) -26.2  (2.39) -19.1  (3.61) -29.5  (1.70) -24.5  (2.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGX-4010 Total, Control, Total
Comments The null hypothesis was that there was no difference between the average percent change in NPRS scores from baseline to weeks 2-12 between the total control and total NGX-4010 groups. The ratio of means between the 30- and 60-minute control group [1.57 (90% CI: 1.12–2.35)] was > than the pre-specified equivalence margin ratio of 80–125%. Hence, the control groups could not be pooled and comparisons were performed between the 30- and 60-minute NGX-4010 groups and their respective control groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0967
Comments All stastical tests of hypotheses were two-sided and at the 5% level of significance.
Method ANCOVA
Comments Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NGX-4010, 60 Minutes, Control Group, 60 Minutes
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4884
Comments All stastical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustment were made.
Method ANCOVA
Comments Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection NGX-4010, 30 Minutes, Control Group , 30 Minutes
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1031
Comments All stastical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustment were made.
Method ANCOVA
Comments Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.
2.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Weeks 2-12.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NGX-4010, 60 Minutes Control Group, 60 Minutes NGX-4010, 30 Minutes Control Group , 30 Minutes NGX-4010 Total Control, Total
Hide Arm/Group Description:
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.
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.
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.
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.
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 or 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 30 or 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.
Overall Number of Participants Analyzed 165 90 167 72 332 162
Least Squares Mean (Standard Error)
Unit of Measure: Numeric Pain Rating Scale (0 to 10)
-2.0  (0.15) -1.8  (0.20) -1.6  (0.14) -1.1  (0.22) -1.8  (0.10) -1.4  (0.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGX-4010 Total, Control, Total
Comments The null hypothesis was: "There is no difference between the total Control and total NGX-4010 in the absolute change in NPRS scores from Baseline during Weeks 2-12."
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0831
Comments All statistical tests of hypotheses were two-sided and at the 5% level of significance.
Method ANCOVA
Comments Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NGX-4010, 60 Minutes, Control Group, 60 Minutes
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4680
Comments All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.
Method ANCOVA
Comments Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection NGX-4010, 30 Minutes, Control Group , 30 Minutes
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0896
Comments All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.
Method ANCOVA
Comments Treatment differences were compared by a gender stratified analysis of covariance (ANCOVA) model with Baseline pain score as the only covariate.
3.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Weeks 2-12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title NGX-4010, 60 Minutes Control Group, 60 Minutes NGX-4010, 30 Minutes Control Group , 30 Minutes NGX-4010 Total Control, Total
Hide Arm/Group Description:
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.
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.
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.
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.
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 or 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 30 or 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.
Overall Number of Participants Analyzed 165 90 167 72 332 162
Measure Type: Number
Unit of Measure: Percentage of Participants
48 45 39 26 43 36
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection NGX-4010 Total, Control, Total
Comments The null hypothesis was: "There is no difference between the total Control and total NGX-4010 group in the Proportion of Subjects Reaching 30% Decrease in Their Mean "Average Pain for the Past 24 Hours" NPRS Score From Baseline During Weeks 2 to 12."
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0662
Comments All statistical tests of hypotheses were two-sided and at the 5% level of significance.
Method Regression, Logistic
Comments A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection NGX-4010, 60 Minutes, Control Group, 60 Minutes
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5582
Comments All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.
Method Regression, Logistic
Comments A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection NGX-4010, 30 Minutes, Control Group , 30 Minutes
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0553
Comments All statistical tests of hypotheses were two-sided and at the 5% level of significance. No multiplicity adjustments were made.
Method Regression, Logistic
Comments A logistic regression analysis, with the Baseline NPRS score and gender as covariates, was performed.
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title NGX-4010, 60 Minutes Control Group, 60 Minutes NGX-4010, 30 Minutes Control Group , 30 Minutes NGX-4010 Total Control, Total
Hide Arm/Group Description 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. 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. 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. 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. 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 or 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 30 or 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.
All-Cause Mortality
NGX-4010, 60 Minutes Control Group, 60 Minutes NGX-4010, 30 Minutes Control Group , 30 Minutes NGX-4010 Total Control, Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
NGX-4010, 60 Minutes Control Group, 60 Minutes NGX-4010, 30 Minutes Control Group , 30 Minutes NGX-4010 Total Control, Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/165 (7.88%)      7/90 (7.78%)      6/167 (3.59%)      2/72 (2.78%)      19/332 (5.72%)      9/162 (5.56%)    
Cardiac disorders             
Acute coronary syndrome  1  0/165 (0.00%)  0 1/90 (1.11%)  1 0/167 (0.00%)  0 0/72 (0.00%)  0 0/332 (0.00%)  0 1/162 (0.62%)  1
Mitral valve incompetence  1  0/165 (0.00%)  0 1/90 (1.11%)  1 0/167 (0.00%)  0 0/72 (0.00%)  0 0/332 (0.00%)  0 1/162 (0.62%)  1
Myocardial infarction  1  0/165 (0.00%)  0 2/90 (2.22%)  2 0/167 (0.00%)  0 0/72 (0.00%)  0 0/332 (0.00%)  0 2/162 (1.23%)  2
Gastrointestinal disorders             
Abdominal pain  1  0/165 (0.00%)  0 0/90 (0.00%)  0 1/167 (0.60%)  1 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Gastrooesophageal reflux disease  1  1/165 (0.61%)  1 0/90 (0.00%)  0 0/167 (0.00%)  0 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Odynophagia  1  0/165 (0.00%)  0 0/90 (0.00%)  0 1/167 (0.60%)  1 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Oesophageal varices haemorrhage  1  0/165 (0.00%)  0 0/90 (0.00%)  0 1/167 (0.60%)  1 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Pancreatitis acute  1  0/165 (0.00%)  0 1/90 (1.11%)  1 0/167 (0.00%)  0 0/72 (0.00%)  0 0/332 (0.00%)  0 1/162 (0.62%)  1
General disorders             
Non-cardiac chest pain  1  0/165 (0.00%)  0 1/90 (1.11%)  1 0/167 (0.00%)  0 0/72 (0.00%)  0 0/332 (0.00%)  0 1/162 (0.62%)  1
Hepatobiliary disorders             
Cholecystitis  1  1/165 (0.61%)  1 0/90 (0.00%)  0 0/167 (0.00%)  0 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Cholecystitis acute  1  0/165 (0.00%)  0 0/90 (0.00%)  0 1/167 (0.60%)  1 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Infections and infestations             
Appendicitis  1  1/165 (0.61%)  1 0/90 (0.00%)  0 0/167 (0.00%)  0 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Gastroenteritis  1  0/165 (0.00%)  0 0/90 (0.00%)  0 0/167 (0.00%)  0 1/72 (1.39%)  1 0/332 (0.00%)  0 1/162 (0.62%)  1
Giardiasis  1  0/165 (0.00%)  0 1/90 (1.11%)  1 0/167 (0.00%)  0 0/72 (0.00%)  0 0/332 (0.00%)  0 1/162 (0.62%)  1
Hepatitis C  1  1/165 (0.61%)  1 0/90 (0.00%)  0 0/167 (0.00%)  0 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Lower respiratory tract infection  1  2/165 (1.21%)  2 0/90 (0.00%)  0 0/167 (0.00%)  0 0/72 (0.00%)  0 2/332 (0.60%)  2 0/162 (0.00%)  0
Meningitis  1  1/165 (0.61%)  1 0/90 (0.00%)  0 0/167 (0.00%)  0 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Meningitis tuberculous  1  0/165 (0.00%)  0 1/90 (1.11%)  1 0/167 (0.00%)  0 0/72 (0.00%)  0 0/332 (0.00%)  0 1/162 (0.62%)  1
Peritonitis bacterial  1  1/165 (0.61%)  1 0/90 (0.00%)  0 0/167 (0.00%)  0 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Pneumonia  1  0/165 (0.00%)  0 0/90 (0.00%)  0 1/167 (0.60%)  1 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Subcutaneous abscess  1  1/165 (0.61%)  1 0/90 (0.00%)  0 0/167 (0.00%)  0 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Urosepsis  1  0/165 (0.00%)  0 0/90 (0.00%)  0 1/167 (0.60%)  1 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Injury, poisoning and procedural complications             
Polytraumatism  1  1/165 (0.61%)  1 0/90 (0.00%)  0 0/167 (0.00%)  0 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Nervous system disorders             
Haemorrhagic stroke  1  0/165 (0.00%)  0 0/90 (0.00%)  0 1/167 (0.60%)  1 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Subarachnoid haemorhage  1  1/165 (0.61%)  1 0/90 (0.00%)  0 0/167 (0.00%)  0 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Psychiatric disorders             
Depression  1  1/165 (0.61%)  1 0/90 (0.00%)  0 0/167 (0.00%)  0 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Suicidal ideation  1  0/165 (0.00%)  0 0/90 (0.00%)  0 0/167 (0.00%)  0 1/72 (1.39%)  1 0/332 (0.00%)  0 1/162 (0.62%)  1
Renal and urinary disorders             
Nephrolithiasis  1  0/165 (0.00%)  0 0/90 (0.00%)  0 1/167 (0.60%)  1 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Chronic obstructive pulmonary disease  1  1/165 (0.61%)  1 0/90 (0.00%)  0 0/167 (0.00%)  0 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Pneumothorax  1  1/165 (0.61%)  1 0/90 (0.00%)  0 0/167 (0.00%)  0 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Vascular disorders             
Arteriosclerosis  1  1/165 (0.61%)  1 0/90 (0.00%)  0 0/167 (0.00%)  0 0/72 (0.00%)  0 1/332 (0.30%)  1 0/162 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
NGX-4010, 60 Minutes Control Group, 60 Minutes NGX-4010, 30 Minutes Control Group , 30 Minutes NGX-4010 Total Control, Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   160/165 (96.97%)      73/90 (81.11%)      149/167 (89.22%)      61/72 (84.72%)      309/332 (93.07%)      134/162 (82.72%)    
General disorders             
Application site erythema  1  97/165 (58.79%)  97 34/90 (37.78%)  34 79/167 (47.31%)  79 24/72 (33.33%)  24 176/332 (53.01%)  176 58/162 (35.80%)  58
Application site pain  1  139/165 (84.24%)  139 29/90 (32.22%)  29 135/167 (80.84%)  135 33/72 (45.83%)  33 274/332 (82.53%)  274 62/162 (38.27%)  62
Musculoskeletal and connective tissue disorders             
Pain in extremity  1  10/165 (6.06%)  10 4/90 (4.44%)  4 10/167 (5.99%)  10 2/72 (2.78%)  2 20/332 (6.02%)  20 6/162 (3.70%)  6
Nervous system disorders             
Peripheral sensory neuropathy  1  5/165 (3.03%)  5 7/90 (7.78%)  7 7/167 (4.19%)  7 12/72 (16.67%)  12 12/332 (3.61%)  12 19/162 (11.73%)  19
Skin and subcutaneous tissue disorders             
Erythema  1  2/165 (1.21%)  2 5/90 (5.56%)  5 3/167 (1.80%)  3 4/72 (5.56%)  4 5/332 (1.51%)  5 9/162 (5.56%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA version 9.0
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.
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 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 from the time submitted to the sponsor for review. The PI shall comply with the sponsor's requests to delete references to trade secrets, intellectual properties or other proprietary information.
Results Point of Contact
Name/Title: Trudy Vanhove, VP Clinical Development
Organization: NeurogesX
Phone: 650-393-7444
Responsible Party: Trudy Vanhove, VP Clinical Development, NeurogesX
ClinicalTrials.gov Identifier: NCT00321672     History of Changes
Other Study ID Numbers: C119
First Submitted: May 2, 2006
First Posted: May 4, 2006
Results First Submitted: June 16, 2010
Results First Posted: June 14, 2011
Last Update Posted: June 14, 2011