Trial Outcomes & Findings for Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy (NCT NCT00321672)
NCT ID: NCT00321672
Last Updated: 2011-06-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
494 participants
Primary outcome timeframe
Weeks 2-12
Results posted on
2011-06-14
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
165
|
89
|
167
|
73
|
|
Overall Study
COMPLETED
|
153
|
81
|
156
|
71
|
|
Overall Study
NOT COMPLETED
|
12
|
8
|
11
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
2
|
0
|
|
Overall Study
Noncompliance
|
1
|
2
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
4
|
2
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Too far to travel for visits
|
1
|
0
|
0
|
0
|
|
Overall Study
Incarcerated
|
0
|
0
|
2
|
0
|
|
Overall Study
Moved out of state
|
0
|
1
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Overall Study
Diagnosis of testicular cancer
|
0
|
1
|
0
|
0
|
|
Overall Study
Extensive travel required for new job
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of NGX-4010 for the Treatment of Painful HIV-Associated Neuropathy
Baseline characteristics by cohort
| Measure |
Control Group , 30 Minutes
n=72 Participants
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
n=494 Participants
Total of all reporting groups
|
NGX-4010, 60 Minutes
n=165 Participants
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
n=90 Participants
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
n=167 Participants
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.
|
|---|---|---|---|---|---|
|
Age Continuous
|
49.3 years
STANDARD_DEVIATION 7.78 • n=4 Participants
|
49.7 years
STANDARD_DEVIATION 8.5 • n=21 Participants
|
49.0 years
STANDARD_DEVIATION 8.52 • n=5 Participants
|
50.1 years
STANDARD_DEVIATION 9.33 • n=7 Participants
|
50.5 years
STANDARD_DEVIATION 8.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
63 Participants
n=4 Participants
|
432 Participants
n=21 Participants
|
148 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Weeks 2-12Population: 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.
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.
Outcome measures
| Measure |
NGX-4010, 60 Minutes
n=165 Participants
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
n=90 Participants
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
n=167 Participants
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
n=72 Participants
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.
|
NGX-4010 Total
n=332 Participants
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.
|
Control, Total
n=162 Participants
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.
|
|---|---|---|---|---|---|---|
|
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.
|
-32.8 Percent Change from baseline
Standard Error 2.41
|
-30.0 Percent Change from baseline
Standard Error 3.27
|
-26.2 Percent Change from baseline
Standard Error 2.39
|
-19.1 Percent Change from baseline
Standard Error 3.61
|
-29.5 Percent Change from baseline
Standard Error 1.70
|
-24.5 Percent Change from baseline
Standard Error 2.43
|
SECONDARY outcome
Timeframe: Weeks 2-12.Outcome measures
| Measure |
NGX-4010, 60 Minutes
n=165 Participants
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
n=90 Participants
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
n=167 Participants
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
n=72 Participants
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.
|
NGX-4010 Total
n=332 Participants
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.
|
Control, Total
n=162 Participants
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.
|
|---|---|---|---|---|---|---|
|
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.
|
-2.0 Numeric Pain Rating Scale (0 to 10)
Standard Error 0.15
|
-1.8 Numeric Pain Rating Scale (0 to 10)
Standard Error 0.20
|
-1.6 Numeric Pain Rating Scale (0 to 10)
Standard Error 0.14
|
-1.1 Numeric Pain Rating Scale (0 to 10)
Standard Error 0.22
|
-1.8 Numeric Pain Rating Scale (0 to 10)
Standard Error 0.10
|
-1.4 Numeric Pain Rating Scale (0 to 10)
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Weeks 2-12Outcome measures
| Measure |
NGX-4010, 60 Minutes
n=165 Participants
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
n=90 Participants
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
n=167 Participants
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
n=72 Participants
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.
|
NGX-4010 Total
n=332 Participants
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.
|
Control, Total
n=162 Participants
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.
|
|---|---|---|---|---|---|---|
|
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
|
48 Percentage of Participants
|
45 Percentage of Participants
|
39 Percentage of Participants
|
26 Percentage of Participants
|
43 Percentage of Participants
|
36 Percentage of Participants
|
Adverse Events
NGX-4010, 60 Minutes
Serious events: 13 serious events
Other events: 160 other events
Deaths: 0 deaths
Control Group, 60 Minutes
Serious events: 7 serious events
Other events: 73 other events
Deaths: 0 deaths
NGX-4010, 30 Minutes
Serious events: 6 serious events
Other events: 149 other events
Deaths: 0 deaths
Control Group , 30 Minutes
Serious events: 2 serious events
Other events: 61 other events
Deaths: 0 deaths
NGX-4010 Total
Serious events: 19 serious events
Other events: 309 other events
Deaths: 0 deaths
Control, Total
Serious events: 9 serious events
Other events: 134 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NGX-4010, 60 Minutes
n=165 participants at risk
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
n=90 participants at risk
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
n=167 participants at risk
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
n=72 participants at risk
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.
|
NGX-4010 Total
n=332 participants at risk
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.
|
Control, Total
n=162 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/165 • 12 weeks
|
1.1%
1/90 • Number of events 1 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.00%
0/332 • 12 weeks
|
0.62%
1/162 • Number of events 1 • 12 weeks
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/165 • 12 weeks
|
1.1%
1/90 • Number of events 1 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.00%
0/332 • 12 weeks
|
0.62%
1/162 • Number of events 1 • 12 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/165 • 12 weeks
|
2.2%
2/90 • Number of events 2 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.00%
0/332 • 12 weeks
|
1.2%
2/162 • Number of events 2 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/165 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.60%
1/167 • Number of events 1 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.61%
1/165 • Number of events 1 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/165 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.60%
1/167 • Number of events 1 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/165 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.60%
1/167 • Number of events 1 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/165 • 12 weeks
|
1.1%
1/90 • Number of events 1 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.00%
0/332 • 12 weeks
|
0.62%
1/162 • Number of events 1 • 12 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/165 • 12 weeks
|
1.1%
1/90 • Number of events 1 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.00%
0/332 • 12 weeks
|
0.62%
1/162 • Number of events 1 • 12 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.61%
1/165 • Number of events 1 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/165 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.60%
1/167 • Number of events 1 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Infections and infestations
Appendicitis
|
0.61%
1/165 • Number of events 1 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/165 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
1.4%
1/72 • Number of events 1 • 12 weeks
|
0.00%
0/332 • 12 weeks
|
0.62%
1/162 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Giardiasis
|
0.00%
0/165 • 12 weeks
|
1.1%
1/90 • Number of events 1 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.00%
0/332 • 12 weeks
|
0.62%
1/162 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Hepatitis C
|
0.61%
1/165 • Number of events 1 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
1.2%
2/165 • Number of events 2 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.60%
2/332 • Number of events 2 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Infections and infestations
Meningitis
|
0.61%
1/165 • Number of events 1 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Infections and infestations
Meningitis tuberculous
|
0.00%
0/165 • 12 weeks
|
1.1%
1/90 • Number of events 1 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.00%
0/332 • 12 weeks
|
0.62%
1/162 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Peritonitis bacterial
|
0.61%
1/165 • Number of events 1 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Infections and infestations
Pneumonia
|
0.00%
0/165 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.60%
1/167 • Number of events 1 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
0.61%
1/165 • Number of events 1 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Infections and infestations
Urosepsis
|
0.00%
0/165 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.60%
1/167 • Number of events 1 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Injury, poisoning and procedural complications
Polytraumatism
|
0.61%
1/165 • Number of events 1 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/165 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.60%
1/167 • Number of events 1 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Nervous system disorders
Subarachnoid haemorhage
|
0.61%
1/165 • Number of events 1 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Psychiatric disorders
Depression
|
0.61%
1/165 • Number of events 1 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/165 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
1.4%
1/72 • Number of events 1 • 12 weeks
|
0.00%
0/332 • 12 weeks
|
0.62%
1/162 • Number of events 1 • 12 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/165 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.60%
1/167 • Number of events 1 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.61%
1/165 • Number of events 1 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.61%
1/165 • Number of events 1 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
|
Vascular disorders
Arteriosclerosis
|
0.61%
1/165 • Number of events 1 • 12 weeks
|
0.00%
0/90 • 12 weeks
|
0.00%
0/167 • 12 weeks
|
0.00%
0/72 • 12 weeks
|
0.30%
1/332 • Number of events 1 • 12 weeks
|
0.00%
0/162 • 12 weeks
|
Other adverse events
| Measure |
NGX-4010, 60 Minutes
n=165 participants at risk
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
n=90 participants at risk
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
n=167 participants at risk
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
n=72 participants at risk
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.
|
NGX-4010 Total
n=332 participants at risk
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.
|
Control, Total
n=162 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
General disorders
Application site erythema
|
58.8%
97/165 • Number of events 97 • 12 weeks
|
37.8%
34/90 • Number of events 34 • 12 weeks
|
47.3%
79/167 • Number of events 79 • 12 weeks
|
33.3%
24/72 • Number of events 24 • 12 weeks
|
53.0%
176/332 • Number of events 176 • 12 weeks
|
35.8%
58/162 • Number of events 58 • 12 weeks
|
|
General disorders
Application site pain
|
84.2%
139/165 • Number of events 139 • 12 weeks
|
32.2%
29/90 • Number of events 29 • 12 weeks
|
80.8%
135/167 • Number of events 135 • 12 weeks
|
45.8%
33/72 • Number of events 33 • 12 weeks
|
82.5%
274/332 • Number of events 274 • 12 weeks
|
38.3%
62/162 • Number of events 62 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.1%
10/165 • Number of events 10 • 12 weeks
|
4.4%
4/90 • Number of events 4 • 12 weeks
|
6.0%
10/167 • Number of events 10 • 12 weeks
|
2.8%
2/72 • Number of events 2 • 12 weeks
|
6.0%
20/332 • Number of events 20 • 12 weeks
|
3.7%
6/162 • Number of events 6 • 12 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
3.0%
5/165 • Number of events 5 • 12 weeks
|
7.8%
7/90 • Number of events 7 • 12 weeks
|
4.2%
7/167 • Number of events 7 • 12 weeks
|
16.7%
12/72 • Number of events 12 • 12 weeks
|
3.6%
12/332 • Number of events 12 • 12 weeks
|
11.7%
19/162 • Number of events 19 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.2%
2/165 • Number of events 2 • 12 weeks
|
5.6%
5/90 • Number of events 5 • 12 weeks
|
1.8%
3/167 • Number of events 3 • 12 weeks
|
5.6%
4/72 • Number of events 4 • 12 weeks
|
1.5%
5/332 • Number of events 5 • 12 weeks
|
5.6%
9/162 • Number of events 9 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER